Genosyl Gas
Product Images NDC 72385-002

Product Visual Gallery

This gallery contains 507 technical images submitted to the FDA as part of the official labeling for Genosyl (NDC 72385-002). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vero Biotech, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Chemical Structure (Structure)

Chemical structure of nitric oxide, illustrating the bonding between nitrogen and oxygen atoms with lone electron pairs shown.*

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Figure 1 (Genosyl 002)

A line graph titled 'Methemoglobin Concentration - Time Profiles Neonates Inhaling 0, 5, 20 or 80 ppm Nitric Oxide gas' showing percent methemoglobin on the vertical axis and hours of nitric oxide gas administration on the horizontal axis, depicting changes over a 12-hour period for various nitric oxide concentrations. Four distinct lines represent 0, 5, 20, and 80 ppm nitric oxide with corresponding markers and sample sizes, illustrating differing methemoglobin concentration trends over time.*

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Image (Genosyl Om 01)

GENOSYL DS device display panel showing operational interface of GENOSYL nitric oxide gas inhalation system by VERO BIOTECH, INC. The device includes controls, status indicators, and dual cartridge compartments, designed for delivering 0.98 mg/L nitric oxide via respiratory inhalation.*

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Image (Genosyl Om 02)

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Image (Genosyl Om 04)

GENOSYL 0.98 mg/L nitric oxide gas for respiratory inhalation, distributed in a gas cylinder container. The label on the cylinder includes product name, strength, and regulatory labeling, with the labeler VERO BIOTECH, INC. visible on the packaging.*

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Image (Genosyl Om 05)

An illustration showing two connected circular containers or vessels labeled with pressure values. The container on the left is marked with 57 kPa, and the one on the right with 110 kPa, connected by a pipe or conduit with indicated flow direction.*

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Image (Genosyl Om 06)

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Image (Genosyl Om 07)

The image shows a packaging label segment with the text 'LOT' inside a rectangular border, indicating a lot or batch number area typically found on pharmaceutical packaging.*

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GENOSYL 0.98 mg/L nitric oxide gas for respiratory inhalation, packaged in a metal cylinder. The label shows the product name, strength, warnings, handling instructions, and labeler VERO BIOTECH, INC. The container is designed for medical use under prescription.*

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Image (Genosyl Om 15)

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Image (Genosyl Om 16)

GENOSYL 0.98 mg/L nitric oxide gas for respiratory inhalation. The blue and white container image likely represents the gas canister or delivery device. Labeler is VERO BIOTECH, INC. Suitable for human prescription use.*

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Image (Genosyl Om 17)

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Image (Genosyl Om 18)

Chemical structure illustration depicting nitric oxide (NO), represented by the element symbol N connected to O with an arrow pointing upward from the O, indicating its molecular form.*

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A pie chart illustrating percentage values with two segments labeled 95% and 15%. The chart likely represents proportions or composition related to the product or its context.*

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Image (Genosyl Om 24)

An illustration showing temperature indicators with a thermometer icon. It displays two temperature points: -20°C (-4°F) on the left and 60°C (140°F) on the right, suggesting a temperature range or limits, likely related to storage conditions.*

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Image (Genosyl Om 25)

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Image (Genosyl Om 26)

GENOSYL .98 mg/L nitric oxide gas for respiratory inhalation, labeled by VERO BIOTECH, INC. The image shows a small vial with a narrow neck and a translucent body containing the gas product. No additional text or packaging details are visible.*

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Image (Genosyl Om 27)

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Image (Genosyl Om 28)

Image of a medical gas delivery cart, likely used for respiratory inhalation therapy, with a label noting GENOSYL nitric oxide gas. The cart is equipped with shelves, a basket, and four wheels for mobility. The device is associated with VERO BIOTECH, INC., corresponding to the GENOSYL nitric oxide gas product used for inhalation.*

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Image (Genosyl Om 29)

GENOSYL DS, nitric oxide gas inhalation device, displaying a digital screen and control panel on the left side with VERO BIOTECH branding on the right. The device is white with blue and black control elements, used for administering nitric oxide at 0.98 mg/L concentration.*

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Image (Genosyl Om 30)

GENOSYL nitric oxide 0.98 mg/L gas for respiratory inhalation, displayed as a medical device console manufactured by VERO BIOTECH, INC. The device features control panels with digital screens and knobs, mounted on a wheeled stand with a basket for supplies, used for delivery of nitric oxide gas in a clinical setting.*

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Image (Genosyl Om 31)

The image shows a gray metallic medical device, featuring a central control unit with a white label containing text and connection points. The device appears designed for respiratory therapy involving inhaled gases, consistent with the administration of GENOSYL, a nitric oxide gas inhalation product by VERO BIOTECH, INC. No specific product branding or strength markings are visible on the device itself.*

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Image (Genosyl Om 32)

A metal bracket or holder likely used for securing a gas cylinder or related medical equipment. The device is rectangular with raised edges on two sides and a spring mechanism on one edge, designed for respiratory-related applications. No text or branding is visible on the item itself.*

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Image (Genosyl Om 33)

The image shows a metal bracket or holder intended for medical or pharmaceutical use. It is a flat, rectangular metal piece with raised sides and mounting holes. No text or branding is visible on the metal part itself. It does not display packaging or labeling information for Genosyl nitric oxide gas.*

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Image (Genosyl Om 34)

GENOSYL nitric oxide gas delivery tubing set. The tubing is coiled and features connectors at both ends, designed for respiratory inhalation use. Labeled for use with GENOSYL nitric oxide gas with strength .98 mg/L. Manufactured by VERO BIOTECH, INC.*

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Image (Genosyl Om 35)

GENOSYL nitric oxide gas inhalation cartridge labeled with 0.98 mg/L strength. The cartridge is from VERO BIOTECH, INC. and displays manufacturer information and handling instructions. The device is designed for controlled respiratory delivery of nitric oxide medication.*

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Image (Genosyl Om 36)

GENOSYL nitric oxide gas inhalation canister, strength .98 mg/L, labeled by VERO BIOTECH, INC. The image shows an orange and white rectangular metal canister with a white plastic top, featuring the VERO logo and text. This container is designed for respiratory administration via inhalation.*

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Image (Genosyl Om 37)

GENOSYL nitric oxide 0.98 mg/L gas in a transparent plastic inhalation device. The device is cylindrical with a clear body showing internal components and connectors on both ends for respiratory inhalation. Labeling is minimal and printed directly on the plastic.*

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Image (Genosyl Om 38)

GENOSYL nitric oxide 0.98 mg/L gas for respiratory inhalation. The image shows a clear gas cylinder with a white cap and an attached blue and white regulator valve. The labeler is VERO BIOTECH, INC. This packaging is designed for the delivery of inhaled nitric oxide.*

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Image (Genosyl Om 39)

GENOSYL .98 mg/L inhalation gas in a clear cylinder container with a metallic valve and cap. The label on the cylinder shows the proprietary name and dosage strength. The product is labeled by VERO BIOTECH, INC. for respiratory administration of nitric oxide gas.*

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Image (Genosyl Om 40)

GENOSYL nitric oxide gas for respiratory inhalation, shown as a blue and transparent cylindrical gas filter or connector device with a conical shape and connection ports on each end. The device appears designed for use in respiratory gas administration. Labeler: VERO BIOTECH, INC.*

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Image (Genosyl Om 41)

The image shows a cylindrical gas canister labeled GENOSYL with a dosage strength of .98 mg/L nitric oxide for respiratory inhalation. The canister is white and includes printed product and labeler information for VERO BIOTECH, INC., with a connector fitting for use in medical gas delivery systems.*

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Image (Genosyl Om 42)

GENOSYL (nitric oxide) respiratory inhalation gas delivery tubing set shown in the image. The tubing includes various connectors and ports designed for use with the gaseous drug product. The image does not show any packaging or labeling text.*

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Image (Genosyl Om 43)

An illustration showing a coiled length of thin tubing with connectors at each end, likely representing components of a respiratory gas delivery system or medical tubing.*

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Image (Genosyl Om 44)

GENOSYL nitric oxide gas for respiratory inhalation is shown with a connected clear blue medical tubing assembly. The tube features connectors on each end, likely designed for use with inhalation delivery systems. No other labeling or packaging is visible in the image.*

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Image (Genosyl Om 45)

GENOSYL gas inhalation device labeled with proprietary name GENOSYL and the generic name nitric oxide. The device is clear with a cylindrical chamber and attached tubing connector, used for respiratory administration. Labeler is VERO BIOTECH, INC. Strength not visible on the device.*

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Image (Genosyl Om 46)

GENOSYL gas inhalation container with a clear lower chamber and a blue upper cap, used for delivery of nitric oxide at a strength of 0.98 mg/L. The container is designed for respiratory administration and labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 47)

GENOSYL nitric oxide gas for respiratory inhalation is shown in a clear, angled connector or adapter component, likely part of the delivery system. The image focuses on a white plastic elbow-shaped piece without visible text or markings, associated with VERO BIOTECH, INC. packaging.*

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Image (Genosyl Om 48)

GENOSYL 0.98 mg/L nitric oxide gas product in a clear flexible bag with tubing attached. The packaging is designed for respiratory inhalation use, labeled by VERO BIOTECH, INC. The image shows the container holding the gas and its connection apparatus.*

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Image (Genosyl Om 49)

An instructional illustration depicting a medical gas delivery setup with connectors and a valve mechanism, likely related to administration of inhalation gases such as nitric oxide. The drawing is technical, showing the components and assembly of the device for respiratory use.*

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Image (Genosyl Om 50)

GENOSYL contains nitric oxide gas at a concentration of 0.98 mg/L for respiratory inhalation use. The label shows the product name, active ingredient, strength, and specifies it is a human prescription drug. The labeler is VERO BIOTECH, INC. The packaging is gray with black text and includes usage instructions and regulatory information.*

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Image (Genosyl Om 51)

GENOSYL 0.98 mg/L nitric oxide gas in a clear plastic cylinder container. The container has a wider base and a narrower top with ridges for grip. No label or printed text is visible on the container itself. Product is manufactured by VERO BIOTECH, INC.*

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Image (Genosyl Om 52)

GENOSYL nitric oxide gas inhalation device, showing a clear plastic component likely used for respiratory administration. The image depicts a single unit without visible text or markings, related to VERO BIOTECH, INC.'s product with strength .98 mg/L.*

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Image (Genosyl Om 53)

GENOSYL (nitric oxide) inhalation gas in a portable white cylinder with a blue valve knob. The product is supplied by VERO BIOTECH, INC. The cylinder is designed for respiratory administration and contains .98 mg/L strength.*

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Image (Genosyl Om 54)

GENOSYL nitric oxide gas in a clear, cylindrical container with a white cap. The packaging appears to be a medical gas container or cylinder designed for respiratory inhalation use. The product is labeled as manufactured by VERO BIOTECH, INC.*

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Image (Genosyl Om 55)

GENOSYL nitric oxide gas for respiratory inhalation shown as a clear medical gas delivery tubing set with a Y-connector and attached nosepiece. No packaging or labeling text is visible in this image. The tubing appears flexible and transparent.*

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Image (Genosyl Om 56)

GENOSYL 0.98 mg/L nitric oxide gas in a large metallic cylinder with a white product label. The label displays the product name, concentration, and important handling instructions. The cylinder is intended for respiratory inhalation use. Labeler: VERO BIOTECH, INC.*

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Image (Genosyl Om 57)

GENOSYL nitric oxide gas in a tall metallic cylinder. The label includes the product name GENOSYL and indicates inhalation as the route. The cylinder is coded with safety and regulatory marks, and the labeler VERO BIOTECH, INC. is referenced. Strength details are not clearly visible in the image.*

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Image (Genosyl Om 58)

GENOSYL 0.98 mg/L nitric oxide gas in a metal cylinder with pressure gauge and valve assembly. The label shows the product name, active ingredient, strength, and the metal cylinder designed for respiratory inhalation use. Manufactured by Vero Biotech, Inc.*

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GENOSYL nitric oxide gas delivery assembly for respiratory inhalation. The image shows a clear plastic Y-shaped tubing device with connectors typical for medical gas administration. The device appears designed for use with GENOSYL nitric oxide at the 0.98 mg/L strength, labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 60)

An instructional illustration showing a respiratory inhalation setup for GENOSYL (nitric oxide) gas. The image includes connecting tubes, a mask, and components arranged to deliver the inhaled medication. The illustration is technical and focuses on the device assembly.*

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Image (Genosyl Om 61)

GENOSYL (nitric oxide) gas, 0.98 mg/L strength, presented in a black, hard plastic carrying case with secure latch closures. The case is rugged and designed for portability and protection, labeled with the manufacturer VERO BIOTECH, INC. Suitable for respiratory inhalation use.*

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GENOSYL 0.98 mg/L gas for respiratory inhalation, displayed with four white circular canisters. The packaging shows no additional text or graphics. Labeler indicated as VERO BIOTECH, INC.*

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Image (Genosyl Om 64)

GENOSYL DS by VERO BIOTECH is a medical device unit shown mounted on a mobile stand with wheels. The unit features a large digital screen, multiple control knobs, and indicator lights. While this image depicts the physical device used for delivering nitric oxide gas via inhalation, it does not show specific strength or dosage labeling on the device itself.*

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Figure 1 (Genosyl Om 65)

An illustration of the GENOSYL DS device used for delivering GENOSYL nitric oxide gas by respiratory inhalation. It features labeled components: NO Gas Delivery Port, Interactive Touch Screen and Alarms, Dual Cassette Receptacles, Water Trap with Gas Sampling Port, Calibration Port, Manual Ventilation Port, and Adaptive Sensor Port.*

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Figure 2 (Genosyl Om 66)

A line graph titled 'GENOSYL DS Cassette Output Range' showing nitric oxide delivered concentration (ppm) on the vertical axis versus total flow (LPM) on the horizontal axis. The graph features curves indicating minimum and maximum nitric oxide output across a range of flow rates from 0 to 120 LPM.*

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Figure 3 (Genosyl Om 67)

A line graph titled 'GENOSYL DS Cassette Minimum Time to Depletion' showing the relationship between total flow (LPM) on the x-axis and nitric oxide delivered concentration (ppm) on the y-axis. It includes three curves labeled Minimum Output: 24 Hours, Nominal Output: 24 Hours, and Maximum Output: 3.6 Hours, illustrating depletion times for different output levels of GENOSYL nitric oxide gas.*

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Figure 4 (Genosyl Om 68)

A line graph titled 'External Transport Cassette Minimum Time to Depletion' illustrating the relationship between Total Flow (LPM) on the x-axis and Nitric Oxide Delivered Concentration (ppm) on the y-axis. It shows three curves representing Minimum Output (12 hours), Nominal Output (12 hours), and Maximum Output (1.5 hours), with Nitric Oxide concentration decreasing as total flow increases.*

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Image (Genosyl Om 69)

GENOSYL DS device by VERO BIOTECH, INC., shown as a medical gas delivery system for nitric oxide respiratory inhalation. The equipment includes two identical module units labeled GENOSYL DS with display screens and control interfaces, mounted on a rolling stand with a basket for accessories. This device is associated with administering the GENOSYL nitric oxide gas product at .98 mg/L strength.*

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Figure 5 (Genosyl Om 70)

Illustration of a dual-console medical device on a mobile cart used for respiratory gas delivery. The device includes a top console, bottom console, power supplies attached to the cart, which features caster wheels for mobility. The image is labeled to identify each component.*

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Figure 6 (Genosyl Om 71)

Illustration showing a medical device setup with two Gauss alarms mounted on an alarm mount stand with locking casters for mobility. The Gauss Alarm unit is detailed with labels indicating the battery indicator and an alarm volume adjustment knob, highlighting key components of the alarm system.*

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Figure 7 (Genosyl Om 72)

Illustration of a medical equipment stand featuring Gauss alarms. The stand includes an optional tether point labeled '1', a Gauss alarms mount with two alarms installed labeled '2', and a close-up of a Gauss alarm device labeled '3'. The image highlights components related to magnetic field safety monitoring.*

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Figure 8 (Genosyl Om 73)

Diagram of the GENOSYL DS nitric oxide gas delivery device showing labeled components including the power button, battery charge indicator, NO delivery port, water trap with gas sample port, calibration port, manual ventilation port, adaptive sensor port, dual cassettes, and cassette access door. The central display screen shows device status and settings.*

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Figure 9 (Genosyl Om 74)

Illustration of the back panel of a medical or laboratory device showing a black rocker power switch and a circular power connector labeled with arrows.*

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Figure 10 (Genosyl Om 75)

The image shows a medical device labeled with a yellow warning sign containing a black triangle with the letters MR inside. The device is light gray with a blue connector visible on the left side. There is a cautionary warning text box indicating risks associated with the device, which is likely related to the respiratory inhalation use of GENOSYL nitric oxide gas by VERO BIOTECH, INC.*

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Figure 11 (Genosyl Om 76)

GENOSYL DS nitric oxide gas device, labeled with product name, strength .98 mg/L, and manufactured by Vero Biotech, Inc. The label includes a barcode, expiration details, and device identification markings. The unit is designed for respiratory inhalation use.*

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Figure 12 (Genosyl Om 77)

GENOSYL 0.98 mg/L nitric oxide gas packaging container by VERO BIOTECH, INC. The image shows a transparent plastic packaging holding a black gas cylinder with white labels containing product and regulatory information, including strength and manufacturer details.*

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Figure 12 (Genosyl Om 78)

GENOSYL .98 mg/L gas in a clear plastic cassette container labeled with VERO BIOTECH, INC. The cassette has a blue window indicator showing it is ready for use. The label states 'For Hospital Use Only.' The cassette is shown from multiple angles: front, back, and side.*

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Figure 12 (Genosyl Om 79)

The image shows a white rectangular cassette device labeled with VERO BIOTECH, INC., used for the GENOSYL nitric oxide gas inhalation product. It features a cassette state window indicating the status, with a highlighted section noting when the cassette is bleached and unavailable for use. The device is part of the packaging or equipment associated with the 0.98 mg/L nitric oxide gas product.*

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Figure 13 (Genosyl Om 80)

GENOSYL 0.98 mg/L nitric oxide gas in a rectangular orange container with a clear plastic cover. The label on the side includes product and regulatory information. The product is manufactured by VERO BIOTECH, INC. and is for respiratory inhalation use.*

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Figure 13 (Genosyl Om 81)

GENOSYL nitric oxide 0.98 mg/L gas for respiratory inhalation by VERO BIOTECH, INC. The image shows a rectangular orange cassette container with front and back views. The front has a VERO BIOTECH logo and a blue cassette state window indicating it is available for use. The back label includes product identification and manufacturing details.*

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Figure 13 (Genosyl Om 82)

The image shows a white gas cassette device labeled VERO BIOTECH, featuring a circular Cassette State Window indicator. The window displays a pale, bleached state indicating the cassette is unavailable for use. This device is associated with GENOSYL nitric oxide gas for respiratory inhalation.*

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Image (Genosyl Om 83)

GENOSYL nitric oxide gas .98 mg/L dosage form, shown in a clear cylindrical inhalation delivery cartridge with connectors on both ends. The cartridge is transparent with some text and markings visible on its surface. Labeler is VERO BIOTECH, INC.*

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Image (Genosyl Om 84)

GENOSYL (nitric oxide) 0.98 mg/L gas for respiratory inhalation. The image shows a clear flexible tube with connectors at both ends, designed for medical delivery of the gas. Labeler is VERO BIOTECH, INC.*

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Image (Genosyl Om 85)

GENOSYL nitric oxide gas delivery tubing set with connectors for respiratory inhalation administration. The image shows a coiled clear flexible tube with specialized connectors at each end, designed for use with nitric oxide gas therapy. Manufactured by VERO BIOTECH, INC.*

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Image (Genosyl Om 86)

GENOSYL gas product label showing a coiled tubing set used for respiratory inhalation delivery. The image displays clear tubing with connectors at both ends, indicating use in administering nitric oxide gas. The product is labeled with the proprietary name GENOSYL, used for nitric oxide delivery by inhalation.*

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Image (Genosyl Om 87)

The image shows a respiratory inhalation device, likely a medical gas delivery interface with tubing and connectors. It appears designed for administering gases such as nitric oxide for inhalation therapy, associated with the GENOSYL nitric oxide gas product by VERO BIOTECH, INC.*

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Image (Genosyl Om 88)

Packaging label for GENOSYL (nitric oxide) gas, 0.98 mg/L strength, designed for respiratory inhalation. The label shows a cylindrical gas container or cartridge with printed product information including the labeler, Vero Biotech, Inc. The image highlights the dosage form and container type for this prescription drug.*

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Image (Genosyl Om 89)

GENOSYL 0.98 mg/L nitric oxide gas in a clear cylindrical inhalation gas cylinder with a white screw cap. No additional labeling or markings are visible. Manufactured by Vero Biotech, Inc.*

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Image (Genosyl Om 90)

The image shows a medical device consisting of a coiled clear and blue tubing connected to a respiratory inhalation apparatus. It is presumably used for delivering GENOSYL (nitric oxide gas) via respiratory inhalation, as indicated by the product data. No packaging or text is visible in the image.*

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GENOSYL .98 mg/L gas inhalation packaging label by VERO BIOTECH, INC. The label is designed as a cut-out template for a carton or container. It features the product name GENOSYL prominently, the generic name nitric oxide, and strength .98 mg/L. The label includes regulatory and product details in compact text areas.*

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Image (Genosyl Om 92)

GENOSYL .98 mg/L inhalation gas device by VERO BIOTECH, INC. The image shows a clear, small, cylindrical respiratory gas delivery component with connections on both ends, used for administration of nitric oxide by inhalation.*

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Image (Genosyl Om 93)

GENOSYL (nitric oxide) inhalation gas container valve, featuring a metallic cylindrical valve component with a white plastic hand wheel on top for flow control. The image shows the gas delivery valve typically used for respiratory administration. Manufactured by VERO BIOTECH, INC.*

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GENOSYL 0.98 mg/L nitric oxide gas inhalation product bottle. The image shows a clear bottle with a connected blue and white inhalation adapter device. Labeled as a prescription drug by VERO BIOTECH, INC.*

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GENOSYL nitric oxide gas inhalation product containing 0.98 mg/L strength. The image shows a clear, cylindrical gas container or delivery device with connection fittings. The product is labeled under VERO BIOTECH, INC. No additional text or labeling visible.*

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Image (Genosyl Om 96)

GENOSYL (.98 mg/L nitric oxide) respiratory inhalation gas product vial. The image shows a small transparent vial with a round top and a wider base, designed for administration via inhalation. No additional text or packaging details are visible. Labeler: VERO BIOTECH, INC.*

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Image (Genosyl Om 97)

GENOSYL nitric oxide 0.98 mg/L gas dosage form in a clear plastic container with a blue cap, designed for respiratory inhalation. The image shows the container without additional labeling or markings. Manufactured by VERO BIOTECH, INC.*

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GENOSYL nitric oxide inhalation gas product image showing a clear cylindrical gas container with a nozzle and collar, used for respiratory administration. No visible text or labels on the container itself. Labeler is VERO BIOTECH, INC.*

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GENOSYL gas inhalation container shown as a single-use, clear plastic vial with a flange and a nozzle for respiratory inhalation. The container is designed for delivery of nitric oxide at a strength of 0.98 mg/L. The labeler is VERO BIOTECH, INC.*

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Image (Genosyl Om 100)

GENOSYL .98 mg/L nitric oxide gas in a white inhalation cylinder with a black valve on top and a blue coiled hose attached at the bottom, labeled by VERO BIOTECH, INC. The cylinder appears designed for respiratory administration.*

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Image (Genosyl Om 101)

GENOSYL 0.98 mg/L nitric oxide gas in a translucent white cylinder container designed for respiratory inhalation use. The container has markings and a textured grip area. Labeler is VERO BIOTECH, INC.*

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Figure 14 (Genosyl Om 102)

An illustration of tubing assemblies used for respiratory inhalation of GENOSYL (nitric oxide gas) showing labeled connections. The tubing has branches labeled for connection to the top console, bottom console, injection assembly, sample tee, and manual ventilation bag NO adapter, highlighting setup components for gas delivery.*

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Image (Genosyl Om 103)

An instructional diagram depicting three labeled lines related to nitric oxide delivery: a NO Injection Line marked in red, a Sample Line marked in blue, and a Manual Ventilation Line shown as clear. The diagram uses simple icons and arrows to illustrate the lines' functions in respiratory inhalation.*

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Figure 15 (Genosyl Om 104)

Illustration of the GENOSYL DS nitric oxide delivery system showing its front panel with labeled indicators and controls. Key features include battery charge status (1), adaptive sensor status (2), mode switch button (3), console mode display (4), measured NO dose in ppm (5), target NO dose setting (6), menu tab (7), dual cassette status indicator (8), NO2 measured level (9), and O2 measured level in percent (10).*

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Image (Genosyl Om 105)

A digital display screen for a respiratory inhalation device showing Primary Mode with two indicators labeled READY. Features a Target NO setting area in parts per million (ppm) with a 'Set' button and a message indicating 'Flow Sensor Missing 2.5 - 10 LPM.' The word 'Menu' is highlighted at the bottom left corner in red.*

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A device display screen showing alarm settings for a respiratory gas delivery system. The screen includes alarm limit settings for NO (nitric oxide) in ppm, NO2 in ppm, and oxygen percentage, with visible numeric values. Menu options at the bottom include Main, Alarms, Calibration, Events, and Settings, with Alarms highlighted in red.*

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A text panel section titled "Clear Alarm History" with three stacked words in black font on a light grey background. The text likely refers to a feature or function related to alarm systems in the drug's use context.*

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An electronic calibration screen interface for monitoring gas levels including NO, NO2, and O2. The display shows low and high range values in ppm and the status of recent calibrations with dates and times. Tabs at the bottom include Main, Alarms, Calibration (highlighted), Events, and Settings.*

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Packaging label showing the word 'Air' in white text on a blue background, indicating a gas container or related product component.*

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GENOSYL 0.98 mg/L nitric oxide gas label showing the product name prominently with abbreviation 'NO'. Packaged by VERO BIOTECH, INC. for respiratory inhalation use.*

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The image shows a label segment with the chemical symbol 'NO2' printed in bold black letters on a light gray background. This likely represents nitrogen dioxide (NO2), but no additional product details or strength are visible in the image.*

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An illustration showing a button or control labeled 'Start Calibration', likely part of a device or system related to the dosage form of inhaled nitric oxide gas.*

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A text panel with the phrase 'Stop Calibration' displayed clearly. The panel likely relates to instructions or operational status regarding calibration, but no further context is visible in the image.*

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Image (Genosyl Om 119)

The image shows a text panel titled 'Calibration History.' It likely contains data or records related to the calibration of equipment or instruments, though specific details are not fully visible.*

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Image (Genosyl Om 120)

Screenshot of an electronic interface displaying the 'Events' tab, showing a list of date- and time-stamped events related to dosing and calibration activities for a device. Events include dosing modes, calibration start and completion, and alarms. The 'Events' tab is highlighted at the bottom of the screen among other tabs labeled Main, Alarms, Calibration, and Settings.*

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Image (Genosyl Om 122)

Packaging label for GENOSYL gas containing nitric oxide at a strength of 0.98 mg/L. The label displays the proprietary name GENOSYL prominently with the active ingredient nitric oxide. It includes details on the respiratory (inhalation) route and indicates VERO BIOTECH, INC. as the labeler. The NDC number shown is 72385-002.*

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Image (Genosyl Om 123)

An electronic device display screen showing a system configuration interface for gas flow control in manual mode with a flow rate of 10 LPM. The screen includes options such as Shutdown, Display Dosing Usage, Perform Leak Test, and Admin/Service Admin. The Settings tab is circled in red, indicating it is selected or highlighted.*

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A user interface panel displaying a manual mode flow rate setting for a respiratory system. The panel shows the label 'Manual Mode Flow Rate (LPM):' above a selectable numeric value set at 10 liters per minute, indicating adjustable gas flow rate control in liters per minute.*

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Image (Genosyl Om 128)

An instructional illustration titled 'Change Date Time' showing a digital device display and controls, presumably for adjusting date and time settings.*

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Image (Genosyl Om 129)

A text panel showing the phrase 'Use Time Offset' in bold yellow highlighting. The rest of the context or content from the panel is not visible.*

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Image (Genosyl Om 130)

This image shows a text panel with the instruction to 'Perform Leak Test.' It likely pertains to safety or usage procedures for the drug product GENOSYL, a nitric oxide gas for respiratory inhalation.*

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Image (Genosyl Om 131)

A gray rectangular panel labeled 'Admin / Service Area' in black text, likely indicating an administrative or service section related to the product.*

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Image (Genosyl Om 132)

An instructional button or interface element labeled 'Display Dosing Usage,' likely part of a digital or electronic device interface related to medication dosing instructions or information.*

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Image (Genosyl Om 133)

This image shows a label panel with a single line of text indicating 'External Transport Mode: OFF'. It appears to be a status or instruction related to the handling or use of the product GENOSYL (nitric oxide gas). No additional product details or instructions are included in this image.*

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Image (Genosyl Om 134)

A digital device screen interface illustrating system settings for GENOSYL inhalation gas therapy. The display shows a 'SHUTDOWN' status with system configuration details, current date and time, manual mode flow rate set to 10, and options including 'Display Dosing Usage,' 'Perform Leak Test,' and 'Admin / Service Area.' The interface includes navigation tabs at the bottom for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 135)

Text panel showing a setting labeled 'External Transport Mode' with the status set to 'ON'. This indicates a mode or operational status for a device related to the administration of a drug.*

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Image (Genosyl Om 136)

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Image (Genosyl Om 137)

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Image (Genosyl Om 138)

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Image (Genosyl Om 139)

Illustration of a device interface for GENOSYL inhalation gas showing the Primary Mode screen. The display includes indicators for gas levels, a prompt to insert the cassette, and tabs for Main, Alarms, Calibration, Events, and Settings. Two red 'REPLACE' labels are visible on the left side.*

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Image (Genosyl Om 140)

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Image (Genosyl Om 141)

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Image (Genosyl Om 142)

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Image (Genosyl Om 143)

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Image (Genosyl Om 145)

An illustration labeled "Cancel Leak Test" displaying white text on a blue rectangular background. The image suggests a user interface button or screen prompt related to stopping or canceling a leak test procedure.*

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Image (Genosyl Om 146)

An instructional diagram showing a droplet icon with the chemical symbol 'NO' inside it, accompanied by the text 'Switch to Primary', suggesting a step involving switching to a primary source or supply related to nitric oxide gas.*

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Image (Genosyl Om 147)

An instructional illustration showing a switch labeled 'Switch to Manual' with an icon resembling an inhalation device or gas regulator, indicating an option to change operational mode manually.*

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Image (Genosyl Om 148)

An electronic interface screen for entering a numeric target value between 0 and 80, showing the number 20 entered. It includes a numeric keypad with digits 0 through 9, and buttons labeled OK, Cancel, and Clear.*

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Image (Genosyl Om 149)

A graphical flowchart illustrating total flow rate categories: less than 2.5 LPM, 2.5 to 10 LPM, and greater than 10 LPM. The flow rate ranges are displayed in separate colored boxes to denote different levels of respiratory gas flow.*

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Image (Genosyl Om 150)

A digital display interface showing settings for a gas delivery system, specifically for nitric oxide (NO). The screen displays the estimated NO concentration in parts per million (ppm) set at 20, with controls to increase or decrease the value. Below, the flow rate is set to 10 liters per minute (LPM) with options to select different flow rates including 8, 10, 15, and 20 LPM.*

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Image (Genosyl Om 151)

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Image (Genosyl Om 156)

An illustration depicting two red, vertically oriented tablet-like shapes with the words 'REPLACE' on each. They are connected by curved arrows indicating a interchangeable or replacement process between the two shapes.*

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Image (Genosyl Om 157)

The image shows two warning labels intended for use with GENOSYL nitric oxide inhalation gas. Both labels have a green background with the word 'WARNING' printed vertically in black capital letters. These labels likely accompany the product packaging or equipment for safe handling and use.*

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Image (Genosyl Om 158)

An illustration showing two green rectangular tabs labeled with the word 'READY' vertically on each side, separated by a central narrow gap. The illustration appears to be instructional or related to preparation steps for use.*

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Image (Genosyl Om 159)

An instructional diagram showing two adjacent tabs labeled "READY" in green on the left and "DOSING" in green on the right. This image likely illustrates device operational states or stages related to the administration of the drug GENOSYL (nitric oxide gas).*

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Image (Genosyl Om 160)

An instructional diagram showing a comparison between RED and GREEN sections labeled REPLACE and DOSING respectively, with 100% indicated in the green section. This likely represents a visual aid related to dosing or replacement instructions for a medical gas product.*

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Image (Genosyl Om 161)

An illustration showing a transition between two green dosing devices, each labeled with the word 'DOSING' in white text. The graphic indicates a directional movement from the left device to the right device using a series of black arrows and the word 'Transition' above the arrows.*

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Image (Genosyl Om 162)

An instructional diagram divided into two vertical halves: a red section labeled "REPLACE 5%" on the left and a yellow section labeled "DOSING" on the right, likely related to dosage or replacement instructions for the GENOSYL nitric oxide inhalation gas product by VERO BIOTECH, INC.*

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Image (Genosyl Om 163)

Packaging label for GENOSYL, a nitric oxide gas for respiratory inhalation. The label shows a red background with white text indicating 'REPLACE' and 'DOSING 0m 0%'. The label is marked with strength .98 mg/L and is produced by VERO BIOTECH, INC.*

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Image (Genosyl Om 164)

An instructional illustration showing two gas cylinder-like shapes side by side. The left cylinder is red with the word 'USED' in white, and the right cylinder is an outline with a large X through it, connected by a circular arrow indicating a replacement or exchange process.*

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Image (Genosyl Om 165)

Illustration showing a graphical representation of a device or component with a highlighted section labeled "READY" in green, likely indicating operational status or readiness for use.*

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Image (Genosyl Om 166)

The image shows a single red vial or ampule with a sealed top containing GENOSYL, a nitric oxide gas for respiratory inhalation. The label includes the proprietary name GENOSYL and likely dosage information, consistent with a .98 mg/L strength. It is labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 167)

GENOSYL 0.98 mg/L nitric oxide gas label with a bright red background featuring white text stating "EXPIRED" in bold letters, indicating the product is past its expiration date.*

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Image (Genosyl Om 168)

GENOSYL (nitric oxide) gas for respiratory inhalation, strength .98 mg/L, from VERO BIOTECH, INC. The image shows a red label with white text displaying the words 'WRONG TYPE' vertically.*

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Image (Genosyl Om 169)

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Image (Genosyl Om 170)

GENOSYL (nitric oxide) 0.98 mg/L inhalation gas in a small, cylindrical medical gas cylinder with a brass valve at the top, labeled by Vero Biotech, Inc. The cylinder is primarily a medium green color on the body with a light green, slightly transparent base.*

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Image (Genosyl Om 171)

A user interface screen displaying primary mode status for a device related to GENOSYL nitric oxide gas administration. The screen shows two readiness indicators labeled READY, a prompt to switch to manual mode, a nitric oxide (NO) symbol, and a message stating Flow Not Detected. The interface includes navigation tabs at the bottom for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 172)

GENOSYL .98 mg/L nitric oxide gas for respiratory inhalation is presented in a numbered metal cylinder. The cylinder label includes the product name GENOSYL with the strength .98 mg/L and the active ingredient nitric oxide. The labeler is VERO BIOTECH, INC.*

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Image (Genosyl Om 173)

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Image (Genosyl Om 174)

Image of a GENOSYL DS device used for delivering nitric oxide gas via respiratory inhalation. The device features a digital screen displaying settings and status, control knobs, and a compartment where a person is adjusting or replacing a cartridge or component on the right side. The device appears designed for clinical or prescription use.*

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Image (Genosyl Om 175)

Label for GENOSYL gas, nitric oxide, dosage strength 0.98 mg/L, used via respiratory inhalation. The label is narrow and vertically oriented, with the single text 'READY' displayed in black letters on a green background. The label is likely part of the product packaging or a status indicator sticker from Vero Biotech, Inc.*

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Figure 16 (Genosyl Om 176)

An instructional diagram titled 'Water Trap / Sample Line Leak Test' showing a sample line setup with a stopcock valve and water trap device. The diagram includes labels on the components and a progress bar indicating 'Test in Progress' with a countdown in seconds, accompanied by a 'Cancel Leak Test' button below.*

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Figure 16 (Genosyl Om 177)

Illustration showing a Water Trap / Sample Line Leak Test procedure with instructions to open the stopcock and press the "Accept" button. The diagram includes a schematic of the equipment and an indication that the test has passed.*

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Image (Genosyl Om 178)

GENOSYL nitric oxide gas packaging label in green with the word SAVE printed vertically in black on the front face of the container. The label design includes cut-out notches on the top and bottom edges.*

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Image (Genosyl Om 179)

GENOSYL nitric oxide gas inhalation container label with a red background and the word 'DISPOSE' printed vertically in black letters. The label is shaped with notched sides, typically used for a gas cylinder or container.*

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Image (Genosyl Om 180)

The image shows a gas cylinder label for GENOSYL containing nitric oxide at a strength of .98 mg/L. The gaseous pharmaceutical product is intended for respiratory inhalation and is labeled by VERO BIOTECH, INC. The label is shaped to fit the cylinder and includes areas for printing regulatory and product information.*

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Image (Genosyl Om 181)

GENOSYL DS nitric oxide gas inhalation device from VERO BIOTECH, INC. The image shows two views of the same unit, a medical device for delivering inhaled nitric oxide, mounted on a mobile stand with wheels and a wire basket. The control panel features a screen and various controls labeled with the brand and model.*

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Figure 17 (Genosyl Om 182)

An instructional diagram illustrating the assembly and components of the GENOSYL (nitric oxide) gas delivery system for respiratory inhalation. It labels parts including the injection assembly with adaptive sensor, GENOSYL port, calibration port, manual ventilation and oxygen tubing components, ventilator connections, and humidifier, among others. The diagram also shows flow lines for NO dosing, injection, and sample pathways.*

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Figure 18 (Genosyl Om 183)

An instructional diagram showing the assembly and connections of the GENOSYL nitric oxide gas delivery system with an adaptive sensor. The schematic labels components including the mixer assembly, sensors, dosing and injection ports, manual ventilation elements, ventilator connections, and humidifier, illustrating the flow and integration of the nitric oxide gas for respiratory inhalation therapy.*

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Figure 19 (Genosyl Om 184)

An instructional diagram illustrating the assembly of the GENOSYL (nitric oxide) gas delivery system. The diagram labels components such as the injection assembly with adaptive sensor, breathing circuit parts, manual ventilation bag adapter, oxygen tubing, humidifier, and flowmeter, showing the connections and flow paths of nitric oxide dosing, injection, and sampling lines.*

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Figure 20 (Genosyl Om 185)

An instructional diagram illustrating the assembly and components of the GENOSYL (nitric oxide) gas delivery system for respiratory inhalation. Key parts labeled include the injection assembly with adaptive sensor, GENOSYL nitric oxide port, manual ventilation NO dosing port, oxygen tubing, manual ventilation bag with NO adapter, Optiflow Jr adapter, humidifier, air/oxygen blender, and flowmeter. Lines for NO injection, NO dosing, and sampling are color-coded for clarity.*

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Image (Genosyl Om 186)

Illustration of a medical device panel showing various controls and indicators, including a blue and transparent component with a home icon, labeled 'Charge Status,' buttons, connectors, and adjustment dials. It appears to be related to gas delivery or monitoring, relevant to the use of GENOSYL nitric oxide inhalation gas.*

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Figure 21 (Genosyl Om 187)

An instructional diagram illustrating gas flow components in a respiratory setup, showing an Adaptive Sensor connected to a Gas Injection Adapter (22mm ID x 22mm OD) linked further to an Inline Breathing Circuit Filter. Arrows indicate the direction of gas flow between these parts.*

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Image (Genosyl Om 188)

An illustration showing a gas injection adapter labeled as 22mm ID x 22mm OD connected to an inline breathing circuit filter. The adapter and filter are depicted as components for respiratory gas delivery, with a connecting arrow indicating attachment between them.*

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Image (Genosyl Om 189)

An illustration depicting gas flow components related to GENOSYL gas. It shows an Adaptive Sensor on the left and a Gas Injection Adapter with dimensions 22mm ID x 22mm OD on the right, connected by a bidirectional arrow indicating gas flow direction.*

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Figure 22 (Genosyl Om 190)

Diagram illustrating a respiratory gas delivery system featuring a mixer component labeled with gas flow direction, including labeled parts such as an adaptive sensor, injection adapter, adapter, and an inline breathing circuit filter, showing proximal and distal ends. This is likely related to the administration of GENOSYL nitric oxide gas by inhalation.*

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Image (Genosyl Om 191)

An instructional illustration showing an adapter with a 22mm ID by 22mm ID connection and an inline breathing circuit filter component, displayed side by side with a double-headed arrow indicating the adapter connects to the circuit filter.*

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Image (Genosyl Om 192)

An instructional diagram showing a gas flow source connected via a 22mm ID x 22mm LD adapter to a distal component. The illustration highlights the connection point between the gas flow source and the adapter used for respiratory inhalation.*

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Image (Genosyl Om 193)

An instructional diagram illustrating the connection of a gas injection adapter with a 22mm inner diameter by 22mm outer diameter to a proximal gas source. The diagram shows a coupling mechanism for the gas administration setup.*

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Image (Genosyl Om 194)

An illustration showing gas flow through an adaptive sensor connected to a gas injection adapter with 22mm inner diameter by 22mm outer diameter. The diagram includes directional arrows indicating flow and a small valve or control component on the adapter.*

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Image (Genosyl Om 195)

An instructional image showing a hand operating the front panel of a GENOSYL DS device, used for delivering nitric oxide gas via respiratory inhalation. The image focuses on connectors and control knobs for attaching delivery components or adjusting settings on the gas administration device.*

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Image (Genosyl Om 196)

The image shows a GENOSYL DS device, used for delivering nitric oxide gas via respiratory inhalation. A hand is operating a connector, which is attached to tubing linked to the device. The labeler, VERO BIOTECH, is visible on the device's front panel.*

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Image (Genosyl Om 197)

Illustration showing a person connecting tubing to a device labeled GENOSYL DS by VERO BIOTECH. The device appears to be a medical gas delivery system for inhalation, associated with the prescription drug GENOSYL (nitric oxide) 0.98 mg/L.*

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Image (Genosyl Om 198)

Illustration of a digital control panel interface for a medical device administering GENOSYL (nitric oxide) gas. The display shows the primary mode with NO concentration at 20 ppm, target NO set to 20 ppm, NO2 at 0.0 ppm, and O2 at 21%. The interface also indicates readiness and dosing status, with options for Main, Alarms, Calibration, Events, and Settings at the bottom.*

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Image (Genosyl Om 199)

GENOSYL nitric oxide gas inhalation delivery system components, including tubing with connectors and a blue valve, shown assembled for respiratory administration. The image depicts parts associated with the GAS dosage form labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 200)

GENOSYL (nitric oxide) gas administration set includes a red delivery tube and a blue valve assembly with attached clear tubing connectors, designed for respiratory inhalation use. The components appear to be part of the gas delivery system for the 0.98 mg/L strength inhalation product by VERO BIOTECH, INC.*

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Image (Genosyl Om 201)

GENOSYL nitric oxide 0.98 mg/L inhalation gas tubing set in a clear plastic configuration, used for respiratory delivery. The image shows a length of flexible clear tubing with connectors and a valve, labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 202)

Illustration showing a water trap/sample line leak test setup for GENOSYL gas. It depicts components including a stopcock to be closed at the sample line end, a valve, and tubing labeled as sample. A progress bar indicates test duration, with a cancel button for the leak test.*

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Image (Genosyl Om 203)

A digital display panel for a nitric oxide delivery system showing primary mode settings, including NO concentration at 20 ppm, target NO at 20 ppm, NO2 at 0.0 ppm, and oxygen concentration at 21%. The interface includes tabs for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 204)

An illustration showing a closed stopcock valve in a pipe or tubing system. The image highlights the position of the valve handle indicating the stopcock is closed, controlling flow through the system.*

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Image (Genosyl Om 205)

An instructional diagram showing a respiratory gas setup with a labeled sample line on the left, a closed stopcock in the center indicated by arrows, and connections on both ends. The illustration highlights components likely related to gas sampling or flow control in a clinical setting.*

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Image (Genosyl Om 206)

An instructional diagram illustrating a sample line setup for a gas delivery system. It shows a sample line connected via a sample line filter, emphasizing the flow direction of the gas sample.*

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Image (Genosyl Om 207)

An illustration showing a sample line setup with a sample line filter and a closed stopcock valve. The diagram depicts flow direction with arrows and labels the components to explain their connection and function.*

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Image (Genosyl Om 208)

Illustration showing components of a respiratory gas sampling setup, including a sample line, sample line filter, and an open stopcock valve. The labeled parts indicate pathways for gas flow and filtration during inhalation therapy.*

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Image (Genosyl Om 209)

An instructional diagram showing a water trap and sample line setup with directions to close the stopcock at the sample line end. The image includes a test progress bar indicating 22 seconds elapsed and a button labeled 'Cancel Leak Test.' This illustrates how to perform a leak test on the sample line for GENOSYL nitric oxide gas administration.*

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Image (Genosyl Om 210)

An image showing a hand connecting or adjusting a tube to a GENOSYL DS device, used for delivering nitric oxide gas at .98 mg/L by respiratory inhalation. The device is manufactured by VERO BIOTECH, INC. and features control knobs and connectors on its front panel.*

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Image (Genosyl Om 211)

An instructional diagram showing a blue injection adapter connecting to a nitric oxide (NO) injection system. The adapter is labeled with dimensions (22mm ID x 22mm OD). Attached is a NO injection port linked to a NO injection line, which is depicted as a red tube leading from the port.*

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Image (Genosyl Om 212)

An instructional diagram illustrating the setup for gas sampling. It shows a Gas Sample Tee connected to a Sampling Port. A tube connects the Sampling Port to a Luer-Lock Collar, which further connects to the Sample Line, highlighted in blue.*

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Image (Genosyl Om 213)

An illustration showing a stopcock valve that is open, with arrows indicating gas flow direction through the valve and connecting tubing. The diagram also labels a sample line attached to the tubing system, likely related to inhalation gas delivery or sampling.*

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Image (Genosyl Om 214)

An instructional diagram consisting of three sequential illustrations showing the attachment process of a grey rectangular device onto a blue component. Arrows indicate movement from left to right, depicting the device being aligned and secured in place on the blue component from an open to closed position.*

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Image (Genosyl Om 215)

An instructional diagram illustrating the components of a manual ventilation setup for dosing GENOSYL nitric oxide gas. It shows an oxygen source connected via oxygen tubing and oxygen port to a manual ventilation bag with a NO adapter and injection port. The setup includes a manual ventilation NO dosing line, with labeled accessories provided by VERO, Inc including the manual ventilation NO dosing line and GENOSYL DS ventilator circuit components.*

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Image (Genosyl Om 216)

Illustration of a respiratory inhalation apparatus components including a ventilator inspiratory outlet, adaptive sensor, injection adapter, and inline breathing circuit filter arranged in a vertical sequence likely to be part of administration setup for inhalation therapy.*

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Image (Genosyl Om 217)

An instructional diagram showing a respiratory inhalation setup for administering the drug GENOSYL (nitric oxide). It depicts connections from a humidifier through a humidifier temperature probe and sample tee, and then leading to the patient, illustrating the flow path of the gaseous medication.*

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Image (Genosyl Om 218)

An instructional diagram showing the positioning of a nebulizer distal from the inspiratory gas sample tee in a respiratory inhalation setup. Arrows indicate the direction of inspiratory and expiratory flow through connected tubing components.*

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Image (Genosyl Om 219)

An instructional diagram showing a setup for sampling, including a sample line connected to a sample line filter and an open stopcock valve. This illustration likely demonstrates a respiratory inhalation gas sample collection or monitoring process.*

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Image (Genosyl Om 220)

GENOSYL DS by VERO BIOTECH, INC. is a respiratory inhalation gas delivery system for inhaled nitric oxide at .98 mg/L strength. The image shows two identical GENOSYL DS devices mounted on a mobile stand with wheels and a basket, designed for controlled delivery of the drug.*

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Image (Genosyl Om 221)

Illustration showing a hand connecting a black cable with a circular metal connector to the back panel of a medical device labeled with a yellow caution sticker marked 'MR'. The device is mounted on a movable arm, and the image highlights the cable connection process.*

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Image (Genosyl Om 222)

Illustration showing a hand adjusting a control or connector on a piece of medical equipment, which may be related to the administration or monitoring of inhaled nitric oxide gas. A caution label with a magnetic resonance (MR) warning symbol is visible on the device.*

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Image (Genosyl Om 223)

An image showing a medical device labeled GENOSYL DS by Vero Biotech, Inc., used for administering nitric oxide gas for respiratory inhalation. The device includes a screen, various control knobs, and a port or connection point circled in red, indicating an area of interest or operation. A hand is pointing to the circled port, highlighting its importance or usage.*

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Image (Genosyl Om 224)

An electronic device screen interface displaying a “Primary Mode” for respiratory inhalation therapy with nitric oxide. The screen shows two red cassette indicators labeled "REPLACE" and prompts to "Insert Cassette." Tabs for Main, Alarms, Calibration, Events, and Settings are visible at the bottom.*

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Image (Genosyl Om 225)

GENOSYL gaseous nitric oxide 0.98 mg/L inhalation drug label by VERO BIOTECH, INC. The label indicates it is for hospital use only. The packaging includes dosage and regulatory information visible on the top label.*

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Image (Genosyl Om 226)

The image shows a VERO BIOTECH-branded clear plastic component likely related to a device or packaging for GENOSYL, a nitric oxide respiratory gas. The label displays the VERO BIOTECH logo prominently and features a small round blue indicator or button near the center. No specific dosage or product details other than the manufacturer are visible.*

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Image (Genosyl Om 227)

The image shows a GENOSYL DS device used for administering nitric oxide gas by respiratory inhalation. The device features a control panel with a display screen showing dosage settings and operational status. A hand is adjusting components on the right side of the device, which includes gas canisters. This equipment is related to the GENOSYL brand nitric oxide gas product.*

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Image (Genosyl Om 228)

Illustration of a medical device screen showing a Primary Mode interface for nitric oxide gas administration. The display indicates two gas cylinders labeled READY and a prompt to perform a Pass Leak Test to enable dosing. The screen includes navigation tabs labeled Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 229)

An instructional diagram showing the water trap and sample line leak test procedure for a respiratory inhalation device. It includes a labeled setup with components like stopcocks and sample lines, with a progress bar indicating the leak test is in progress at 22 seconds, and buttons to cancel or proceed with the test.*

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Image (Genosyl Om 230)

An instructional diagram titled 'Water Trap / Sample Line Leak Test' showing steps for a leak test procedure including opening the stopcock and pressing the 'Accept' button. The illustration includes graphical elements of the water trap assembly and a highlighted message 'Test PASSED' indicating successful completion.*

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Image (Genosyl Om 231)

Illustration of a Water Trap / Sample Line Leak Test setup used in respiratory inhalation systems. The diagram highlights components like the water trap and tubing connections, and includes a status display showing 'Test FAILED' in red, along with an 'Accept' button for user interaction.*

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Image (Genosyl Om 232)

An instructional screen from GENOSYL DS software displaying a prompt titled 'Repeat Water Trap / Sample Line Leak Test?' with two options: a green 'Confirm' button on the bottom left highlighted by a red circle and arrow, and a beige 'Cancel' button on the bottom right.*

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Image (Genosyl Om 233)

GENOSYL DS, a medical device manufactured by VERO Biotech, Inc., shown as a dual-module respiratory inhalation gas delivery system mounted on a wheeled stand. The device features two displays and multiple control knobs, designed for administration of nitric oxide gas (0.98 mg/L strength). The VERO Biotech logo appears on both modules.*

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Image (Genosyl Om 234)

A digital screen interface displaying a control panel labeled 'Primary Mode' for a respiratory device. It shows two vertical indicators labeled "READY" on the left side and a numeric target setting for NO (nitric oxide) concentration on the right with a button labeled "Set" circled in red. Tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 235)

Illustration of a digital control panel screen for a nitric oxide delivery system used in respiratory inhalation therapy. The screen displays indicators for two ready gas cylinders, primary mode selection, and a numeric keypad for entering the target NO concentration (0-80), with the 'OK' button highlighted. This image relates to settings for GENOSYL nitric oxide gas at 0.98 mg/L, labeled by VERO BIOTECH, INC.*

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Image (Genosyl Om 236)

A digital display illustration showing the monitoring interface for administering nitric oxide gas. The screen displays primary mode settings including nitric oxide concentration (NO) at 20 ppm (parts per million), nitrous oxide (NO2) at 0.0 ppm, and oxygen (O2) at 21%. It has status indicators labeled 'READY' and 'DOSING,' with navigation buttons for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 237)

The image shows a digital display screen from a medical device set to 'Primary Mode' with two green 'READY' indicators and a control panel on the right side showing the target nitric oxide (NO) level at 0 ppm. The 'Set' button is highlighted by a red arrow and circle, indicating where the target NO level can be adjusted. The display also features an 'Adaptive Sensor Meaning' message with a flow rate of less than 2.5 LPM, relevant to the inhalation delivery of nitric oxide gas.*

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Image (Genosyl Om 238)

Interface screen showing settings for GENOSYL (nitric oxide gas) delivery via respiratory inhalation. The display includes a keypad for entering target nitric oxide concentration (0-80), flow rate selection options (<2.5 LPM, 2.5-10 LPM, >10 LPM), and control buttons for OK, Cancel, and Clear. Ready status indicators are visible on the left side.*

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Image (Genosyl Om 239)

The image is a user interface display panel showing primary mode dosing settings for nitric oxide gas. It includes numeric values for NO (nitric oxide) in parts per million (20 ppm), NO2 (nitrogen dioxide, 0 ppm), and O2 (oxygen, 21%). The panel also shows target NO set at 20 ppm, with an adaptive sensor flow range of 2.5 to 10 LPM. Navigation tabs are present at the bottom for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 240)

An electronic display screen showing the primary mode for dosing nitric oxide gas with parameters including NO concentration at 20 ppm, NO2 at 0.0 ppm, and O2 at 21%. The screen includes controls labeled READY and DOSING, a highlight around the 'Set' function for target NO, and navigation tabs at the bottom such as Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 241)

An interface illustration showing a numeric keypad with digits 0-9 and a decimal point for entering a target nitric oxide (NO) level from 0 to 80. The number '20' is entered in the input field above the keypad, and an 'OK' button is highlighted with a red arrow pointing to it, indicating confirmation of the input.*

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Image (Genosyl Om 242)

An electronic control panel screen displaying settings for nitric oxide (NO) administration in primary mode. The screen shows NO concentration at 20 ppm, an adaptive sensor setting of 2.5-10 LPM, and oxygen concentration at 21%. Indicators for Ready and Dosing status are visible on the left side, along with menu tabs including Main, Alarms, Calibration, Events, and Settings at the bottom.*

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Image (Genosyl Om 243)

A digital interface illustration showing a touchscreen for entering target nitric oxide (NO) concentration levels ranging from 0 to 80. The screen displays a numeric keypad with the number 20 entered, along with buttons marked "OK," "Cancel," and "Clear." Flow rate selection buttons labeled with ranges < 2.5 LPM, 2.5 - 10 LPM, and > 10 LPM are visible on the right.*

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Image (Genosyl Om 244)

A digital display panel showing dosing information for nitric oxide (NO) gas therapy. The screen indicates primary mode with a target NO concentration set at 20 ppm, actual NO level at 20 ppm, NO2 concentration at 0.1 ppm, and oxygen percentage at 21%. Two green dosing syringes are illustrated on the left side under 'Dosing.' Control buttons for 'Menu' and switching to manual mode are visible.*

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Image (Genosyl Om 245)

An electronic display screen showing the primary mode for inhaled nitric oxide delivery. The screen indicates nitric oxide (NO) concentration at 20 ppm, nitrogen dioxide (NO2) at 0.0 ppm, and oxygen (O2) at 21%. It features dosing and replace indicators and a target NO setting of 20 ppm. Navigation tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 246)

A digital display screen showing primary mode settings for delivering nitric oxide gas. It features readiness and dosing indicators, with target NO set at 20 ppm, an NO concentration of 0.0 ppm, and oxygen percentage at 21%. The interface includes tabs for Main, Alarms, Calibration, Events, and Settings, and a highlighted button labeled 'Switch to Manual.'*

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Image (Genosyl Om 247)

An instructional screen display showing a prompt for switching to manual dosing for GENOSYL nitric oxide gas inhalation therapy. The interface includes options to 'Confirm' or 'Cancel' the action, with the 'Confirm' button highlighted in red at the bottom left.*

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Image (Genosyl Om 248)

A graphical user interface screen showing manual mode control for administering nitric oxide gas. It displays an estimated NO concentration of 20 ppm and a flow rate of 10 LPM. The screen includes status indicators labeled 'READY' and 'DOSING' with green arrows for adjusting the concentration. Menu tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 249)

An electronic control panel display for a respiratory gas device showing manual mode settings. The screen indicates an estimated nitric oxide (NO) concentration in parts per million (ppm) set at 20, with a selectable flow rate dropdown menu currently set to 10 liters per minute (LPM). Visual indicators include 'READY' and 'DOSING' status bars on the left and a silhouette of connected gas delivery components on the right.*

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Image (Genosyl Om 250)

This image shows a digital control interface screen for GENOSYL nitric oxide gas inhalation therapy. The screen displays primary mode information including an NO concentration of 20 ppm, target NO ppm set to 20, and oxygen concentration at 21%. Tabs at the bottom include Main, Alarms, Calibration, Events, and Setting, with Setting highlighted by a red arrow.*

FDA Label Image

Image (Genosyl Om 251)

An illustration showing a system configuration interface screen for a medical device. It includes manual mode flow rate options for dosage settings, a shutdown button, and navigation tabs labeled Main, Alarms, Calibration, Events, and Settings, with Settings tab highlighted.*

FDA Label Image

Image (Genosyl Om 252)

An illustration of a medical device screen in 'Manual Mode' used for administering GENOSYL (nitric oxide) gas. The display shows dosing and ready status indicators on the left and an estimated NO concentration of 20 ppm with a flow rate of 10 LPM on the right. The top includes a highlighted option to 'Switch to Primary.'*

FDA Label Image

Image (Genosyl Om 253)

An instructional screen capture showing a respiratory dosing confirmation interface for GENOSYL nitric oxide gas. The display includes a prompt to switch to primary dosing at 20 ppm, a graphical representation of an inhalation device, and buttons labeled 'Confirm' (highlighted in red) and 'Cancel' for user interaction.*

FDA Label Image

Image (Genosyl Om 254)

An electronic device interface screen displaying the primary mode for inhaled nitric oxide delivery. The screen shows settings for nitric oxide concentration at 20 ppm, with target NO also set at 20 ppm. Additional indicators include nitrogen dioxide (NO2) at 0.0 ppm and oxygen (O2) concentration at 21%. The interface includes tabs for Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 255)

An electronic display screen showing the user interface of a device monitoring GENOSYL nitric oxide gas delivery. The screen indicates 'Primary Mode' with two green 'READY' labels on gas tanks and a section highlighting the 'Set' option for target nitric oxide concentration with adaptive sensor flow rate below 2.5 LPM. Menu options along the bottom include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 256)

An interface screen of a medical device for controlling nitric oxide gas dosage and flow rate. It shows sections labeled DOSING and READY with a numerical keypad for entering a target nitric oxide concentration (0 to 80 ppm), total flow displayed as 20, and flow rate options divided into < 2.5 LPM, 2.5 - 10 LPM, and > 10 LPM. The screen includes tabs for Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 257)

Illustration showing the GENOSYL D5 device by VERO BIOTECH, INC. The image focuses on the connection point where a hand is attaching a tube to the front panel of the device, which is used for delivering nitric oxide gas via respiratory inhalation.*

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Image (Genosyl Om 258)

GENOSYL DS inhalation gas delivery system by VERO BIOTECH, INC. The image shows a medical device consisting of two digital control units labeled GENOSYL DS mounted on a mobile stand with wheels. The device is designed for controlled delivery of nitric oxide gas, used in respiratory treatments.*

FDA Label Image

Image (Genosyl Om 259)

This image shows a digital interface screen displaying settings for nitric oxide (NO) delivery. It includes primary mode indicators, NO concentration set at 20 ppm, NO2 concentration at 0.0 ppm, and oxygen percentage at 21%. The screen features controls for ready and dosing modes, with a highlighted 'Set' button in red.*

FDA Label Image

Image (Genosyl Om 260)

Illustration of a medical device screen in Primary Mode showing nitric oxide (NO) and nitrogen dioxide (NO2) levels in parts per million (ppm). The screen includes dosing and ready status indicators, a keypad for entering a target NO value (0-80), and buttons labeled OK, Cancel, and Clear. An arrow points to the OK button on the display interface.*

FDA Label Image

Image (Genosyl Om 261)

Screenshot of a control system user interface for medical equipment, highlighting the Shutdown button and the Settings tab. The screen displays system configuration details, current date and time, manual mode flow rate, external transport mode status, and options for leak testing and dosing usage display.*

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Image (Genosyl Om 262)

Illustration showing a software interface screen for shutting down a dosing console. It instructs the user to select the 'Confirm' button, highlighted with a red arrow, to shut down the console and eject dosing cassettes, with specific disposal instructions for the left and right cassettes.*

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Image (Genosyl Om 263)

The image shows a GENOSYL DS device, a gas delivery system labeled with VERO BIOTECH branding. The device has a digital display screen and multiple connection ports, as well as control buttons, indicating its use for administering nitric oxide gas via respiratory inhalation.*

FDA Label Image

Image (Genosyl Om 264)

This image shows a GENOSYL DP nitric oxide gas delivery device by VERO BIOTECH, INC. It highlights the front control panel with various knobs and connectors, as well as a hand interacting with a component on the right side, possibly demonstrating operation or maintenance of the inhalation device.*

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Image (Genosyl Om 265)

An image showing a person's hand adjusting or interacting with a control or connector on a medical device or equipment. The hand is circled in red to highlight this action. The device includes a warning label on the side.*

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Image (Genosyl Om 266)

The image shows a GENOSYL DS dual module nitric oxide delivery system by VERO BIOTECH, INC. It consists of two identical gas delivery units mounted on a mobile cart with wheels, control panels with display screens, knobs, and connectors for respiratory inhalation use.*

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Figure 23 (Genosyl Om 267)

Illustration diagram showing the GENOSYL Delivery System setup with an MR scanner. Labeled components include the GENOSYL delivery units, Gauss Alert, sample line extension, MR scanner and bore, patient table, exclusion zone, and 100 Gauss line. The diagram depicts the spatial arrangement of the equipment in relation to the MRI environment.*

FDA Label Image

Image (Genosyl Om 268)

GENOSYL DS device for administration of nitric oxide gas by respiratory inhalation. The front panel includes a display screen, control knobs, status indicators, and two orange cartridges on the right side. The device is labeled with the proprietary name GENOSYL DS and manufactured by VERO BIOTECH, INC.*

FDA Label Image

Figure 24 (Genosyl Om 269)

Illustration of the GENOSYL DS nitric oxide dosing system console showing the display screen with labeled indicators, buttons, and status icons. Key features include battery charge status, adaptive sensor indicator, mode switch, measured and target nitric oxide dose in ppm, menu tab, dual cassette status, NO2 and O2 measured levels, and external transport symbols.*

FDA Label Image

Figure 25 (Genosyl Om 270)

Illustration of the GENOSYL DS console for nitric oxide gas delivery. The image labels features including the strap, transport mount, door latch, GENOSYL DS console itself, and an optional quick connect plate. The console has a display screen and compartments housing cartridges.*

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Figure 26 (Genosyl Om 271)

Packaging label for GENOSYL, a nitric oxide gas for respiratory inhalation. The label indicates the product strength as 0.98 mg/L and includes manufacturer information for VERO BIOTECH, INC. The container is a clear plastic case holding an orange gas cylinder with visible regulatory and product information labels.*

FDA Label Image

Figure 26 (Genosyl Om 272)

GENOSYL .98 mg/L gas for respiratory inhalation by Vero Biotech, Inc., shown in an orange cassette container. Images display front, back, and side views, highlighting a cassette state window indicating availability for use with a blue status light. Labels on the cassette include lot numbers and usage instructions.*

FDA Label Image

Figure 26 (Genosyl Om 273)

GENOSYL nitric oxide gas inhalation product packaging from VERO BIOTECH, INC., featuring a white container with a cassette state window labeled 'Bleached: Cassette State unavailable for use.' The label includes the VERO BIOTECH logo and shows connection ports on the device.*

FDA Label Image

Image (Genosyl Om 274)

The image shows a medical device labeled GENOSYL DS by VERO BIOTECH. The device appears to be a control or delivery unit for the gas product GENOSYL (nitric oxide) 0.98 mg/L, used for respiratory inhalation. The device screen and several control buttons are visible, along with a mounting bracket indicated by a red arrow in the lower portion of the image.*

FDA Label Image

Image (Genosyl Om 275)

GENOSYL (nitric oxide) inhalation gas device labeled with the VERO BIOTECH, INC. logo. The image shows a medical device with a display screen and control buttons, used for administering inhaled nitric oxide gas, likely related to the 0.98 mg/L strength. The device is white with black and blue components and a handle on top.*

FDA Label Image

Figure 27 (Genosyl Om 276)

Diagram of the GENOSYL nitric oxide gas delivery system components and accessories provided by VERO BIOTECH, INC. The illustration labels the injection assembly with adaptive sensor, manual ventilation bag with connectors, ventilator circuit components including expiratory and inspiratory limbs, sample tee, air/oxygen blender, heat moisture exchanger, and lines for NO dosing, injection, and sampling. Color coding highlights respective lines for injection, dosing, and sampling.*

FDA Label Image

Image (Genosyl Om 277)

An instructional illustration showing four labeled components used in a respiratory gas delivery system: Sample Tee, 3/8" Barbed; Injection Line Filter; Adaptive Sensor; and NO Gas Injection Adapter. Each component is depicted in blue with simple outlines.*

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Image (Genosyl Om 278)

An instructional diagram showing three components labeled NO Gas Injection Adapter, Injection Line Filter, and Adaptive Sensor. The illustration demonstrates how these parts connect, with arrows indicating the assembly sequence.*

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Image (Genosyl Om 279)

Illustration showing a gas injection assembly with an injection line filter connected to a ventilator outlet port. The diagram indicates the setup for delivering gas through the respiratory route, relevant to administration of GENOSYL nitric oxide gas.*

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Image (Genosyl Om 280)

An illustration showing a gas injection assembly with an injection line filter connected to an inspiratory limb inlet. The diagram appears to depict part of a respiratory inhalation system for administering nitric oxide gas.*

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Image (Genosyl Om 281)

An instructional diagram showing a Patient Wye connected to tubing labeled as Non-conjugated Tubing with a cut line marked along the tubing. The diagram likely illustrates part of a respiratory inhalation setup, relevant to the administration of inhaled drugs such as nitric oxide.*

FDA Label Image

Image (Genosyl Om 282)

An illustration diagram showing components of a respiratory inhalation setup for GENOSYL, including a sample tee with a 3/8" barbed connector and a patient wye. The diagram indicates how these parts connect to deliver nitric oxide gas via inhalation.*

FDA Label Image

Image (Genosyl Om 283)

An instructional diagram illustrating the setup of the GENOSYL nitric oxide delivery system for respiratory inhalation. It shows labeled components including the NO Injection Line and the Sample Line Stopcock connected by tubing and valves, guiding appropriate gas delivery and sampling.*

FDA Label Image

Figure 28 (Genosyl Om 284)

Illustration diagram of the GENOSYL nitric oxide delivery system showing labeled components and connections. It details the injection assembly, ports, manual ventilation bag, tubing, transport ventilator, temperature probe, gas sample tee, stopcock, and heat moisture exchanger, with color-coded lines for manual ventilation NO dosing, NO injection, NO sample, adaptive sensor cable, and ventilator circuit components. The diagram serves as a guide to the setup and accessory connections for GENOSYL gas inhalation therapy.*

FDA Label Image

Image (Genosyl Om 285)

Illustration showing four labeled components related to gas delivery or sampling: Gas Sample Tee, Injection Line Filter, Adaptive Sensor, and NO Gas Injection Adapter. Each component is depicted with a simple line drawing and label beneath.*

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Image (Genosyl Om 286)

An instructional diagram showing a NO Gas Injection Adapter with an Injection Line Filter and an Adaptive Sensor. The diagram illustrates how the adapter connects to the sensor, highlighting components involved in the gas injection process.*

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Image (Genosyl Om 287)

An illustration diagram showing a gas injection assembly with an injection line filter connected to a ventilator outlet port. This instructional graphic depicts components relevant to the administration or delivery of the inhalation gas product.*

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Image (Genosyl Om 288)

An instructional diagram showing a gas injection assembly with an injection line filter connected to an inspiratory limb inlet, illustrating the setup for respiratory gas delivery.*

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Image (Genosyl Om 289)

Diagram illustrating the setup for inhalation administration of GENOSYL (nitric oxide gas). It shows a sample tee connected to the patient on one end and a temperature probe on the other, with a labeled connection for measuring temperature.*

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Image (Genosyl Om 290)

An instructional diagram showing a respiratory inhalation setup for administering nitric oxide gas, GENOSYL. The illustration details the NO injection line at the top, connecting to tubing that includes a sample line stopcock for sampling or control.*

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Figure 29 (Genosyl Om 291)

Illustration of VERO Biotech's GENOSYL nitric oxide gas delivery system setup. The diagram labels components including the mixer assembly with adaptive sensor, manual ventilation bag adapter, transport ventilator, oxygen tubing, and associated ports such as NO dosing, sensor, gas injection, and calibration ports. Color-coded lines indicate manual ventilation, NO dosing, NO injection, and sample lines.*

FDA Label Image

Image (Genosyl Om 292)

An instructional illustration showing components of a gas delivery or monitoring system for inhalation use. It includes labeled parts such as Inline Breathing Circuit Filter, Mixer, Adapter (22F x 22F), Adaptive Sensor, NO Gas Injection Adapter, and Gas Sample Tee, each depicted with simple line drawings.*

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Image (Genosyl Om 293)

An instructional diagram showing a respiratory gas delivery system with labeled components including an adapter sensor, mixer, and inlet/outlet tubing, likely depicting the administration setup for GENOSYL nitric oxide gas inhalation.*

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Image (Genosyl Om 294)

Instructional diagram of a ventilator mixer assembly with an adaptive sensor connected to the ventilator outlet port. The illustration shows the configuration and placement of components involved in respiratory inhalation gas delivery.*

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Image (Genosyl Om 295)

Illustration of a mixer assembly with an adaptive sensor designed for respiratory inhalation. The diagram highlights the inspiratory limb inlet and shows the internal components of the mixer, indicating airflow direction and sensor integration. It is related to the administration of GENOSYL (nitric oxide) gas.*

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Image (Genosyl Om 296)

An instructional diagram showing the assembly of respiratory components for GENOSYL gas administration, including connections from a 'Sample Tee' to 'To Patient' tubing and a 'Temperature Probe' linked via a blue cable, illustrating proper setup for inhalation delivery.*

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Image (Genosyl Om 297)

An instructional diagram showing the setup for administering GENOSYL (nitric oxide gas) via respiratory inhalation. The image details tubing connections including the NO injection line and sample line stopcock, demonstrating how to integrate the nitric oxide gas delivery into the breathing circuit.*

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Image (Genosyl Om 298)

An electronic device screen interface displaying a section labeled 'Primary Mode' with a nitric oxide (NO) flow path. The screen shows two red indicators labeled 'REPLACE' on the left, an instruction to 'Insert Cassette' on the right, and navigation tabs at the bottom labeled Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 299)

Screenshot of the settings menu screen for a medical device labeled with system configuration details, current date and time, and options including manual mode, external transport mode status, and buttons to display dosing usage, perform leak test, and access admin/service area.*

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Image (Genosyl Om 300)

A user interface screen showing a confirmation dialogue for turning ON External Transport Mode. The screen displays a prompt with the options "Confirm" and "Cancel," with a red arrow pointing to the "Confirm" button.*

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Image (Genosyl Om 301)

A screenshot of medical device software interface for GENOSYL nitric oxide gas delivery. The screen shows system configuration details, current date and time, and options including Main, Alarms, Calibration, Event Log, and Settings. A numeric PIN entry pop-up prompts for a required code with options to OK and Cancel.*

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Image (Genosyl Om 302)

An instructional diagram showing two red cylinders labeled REPLACE and a red arrow pointing to a circled area with icons of a car, wheelchair, and airplane on a blue background, likely indicating transportation or usage instructions related to the product device or setup.*

FDA Label Image

Image (Genosyl Om 303)

An instrument display screen showing an interface with icons including two red vertical bars labeled REPLACE on the left, and a circled area highlighted by an arrow featuring symbols of a hospital bed with a patient, an ambulance, and an airplane, suggesting use scenarios or settings. The screen also shows text indicators such as Primary Mode and options to Switch to Manual and Insert Cassette.*

FDA Label Image

Image (Genosyl Om 304)

GENOSYL 0.98 mg/L nitric oxide gas packaging in an orange container with a white label. The label shows product details, a barcode, and a QR code. The labeler is VERO BIOTECH, INC. The container is designed for respiratory inhalation use.*

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Image (Genosyl Om 305)

GENOSYL nitric oxide gas delivery device by VERO BIOTECH, INC., shown as a white rectangular unit with the company logo, a circular blue button outlined in red, and connection ports at the top and bottom, intended for respiratory inhalation use.*

FDA Label Image

Image (Genosyl Om 306)

Image of the GENOSYL DS, a medical device used to deliver GENOSYL inhalation gas (nitric oxide) at 0.98 mg/L. The device includes a control panel with display and attached orange gas cylinders labeled for use with GENOSYL. Labeler is VERO BIOTECH, INC.*

FDA Label Image

Image (Genosyl Om 307)

An instructional screen titled "Primary Mode" showing a graphic interface with two vertical green indicators labeled "READY" and a central symbol representing nitric oxide (NO). The screen displays a message "Pass Leak Test To Enable Dosing" and icons of a hospital bed, an ambulance, and an airplane, indicating medical transport modes. There is a menu button in the bottom left corner.*

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Image (Genosyl Om 308)

An instructional diagram showing the Water Trap / Sample Line Leak Test procedure. It illustrates closing the stopcock at the end of the sample line and includes a progress bar indicating test time in seconds, along with a button to cancel the leak test.*

FDA Label Image

Image (Genosyl Om 309)

Illustration showing a Water Trap / Sample Line Leak Test procedure for a respiratory device. The diagram includes a stopcock being pressed to activate and a green bar indicating "Test PASSED." A button labeled "Accept" is shown below the status bar.*

FDA Label Image

Image (Genosyl Om 310)

GENOSYL DS gas delivery system labeled VERO BIOTECH, INC. The device features a digital display screen, multiple control knobs, indicators, and connection ports on a compact white unit. It is designed to administer nitric oxide gas for respiratory inhalation use at a strength of 0.98 mg/L.*

FDA Label Image

Image (Genosyl Om 311)

Illustration of a medical device screen showing settings for nitric oxide delivery. The display includes indicators for cylinder status marked 'READY,' an area labeled 'Primary Mode' with nitric oxide (NO) symbol, and a digital readout for setting the target NO concentration in ppm with a highlighted 'Set' button circled in red.*

FDA Label Image

Image (Genosyl Om 312)

User interface screen of a GENOSYL delivery device showing the dosage setting panel with the target NO concentration set at 20 units. The screen includes buttons for number input, OK, Cancel, and Clear, and displays system status indicators such as READY and mode settings.*

FDA Label Image

Image (Genosyl Om 313)

An electronic user interface screen for a respiratory device showing the 'Primary Mode' for nitric oxide (NO) delivery. The screen indicates two 'READY' status cylinders on the left, a highlighted 'Set' button for target NO in ppm, and adaptive sensor settings with a flow rate greater than 10 LPM. Navigation tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 314)

An interface screen for inhalation gas flow settings related to nitric oxide administration. The display includes options to enter target nitric oxide levels (0-80) via a numeric keypad, current target set at 20, and allows selection of total flow ranges: less than 2.5 LPM, 2.5 to 10 LPM, or greater than 10 LPM. The screen shows 'READY' indicators for two units and has selection buttons for OK, Cancel, and Clear.*

FDA Label Image

Image (Genosyl Om 315)

An electronic device screen display showing settings related to nitric oxide (NO) gas administration. The display indicates primary mode, NO concentration at 20 ppm, target NO set at 20 ppm, and monitoring of NO2 and O2 levels at 0.0%. Additional labels include 'READY' and 'DOSING' status indicators and an alert for 'Adaptive Sensor Missing <2.5 LPM.' The interface includes navigation tabs such as Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 316)

An illustration of a respiratory gas dosing device screen for GENOSYL (nitric oxide) inhalation gas. The screen shows primary mode settings with nitric oxide (NO) levels in parts per million (ppm), including a target NO set at 20 ppm, current NO at 20 ppm, NO2 at 0.0 ppm, and oxygen (O2) concentration at 21%. The display includes buttons/tabs labeled Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 317)

User interface screen for dosing or setting a target concentration of nitric oxide (NO) gas, showing an entered value of 20 with a numeric keypad and highlighted OK button for confirmation.*

FDA Label Image

Image (Genosyl Om 318)

User interface screen of a respiratory gas dosing device displaying nitric oxide (NO) delivery settings. It shows primary mode activated with NO concentration set at 20 ppm. Indicators for NO2 and O2 levels are present, along with dosing and ready status bars. Tabs labeled Main, Alarms, Calibration, Events, and Settings are visible at the bottom.*

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Image (Genosyl Om 319)

An instructional illustration showing a medical device interface with a prompt to switch to manual dosing, highlighting a connector plugged into a port and two on-screen buttons labeled 'Confirm' and 'Cancel', with the 'Confirm' button circled in red.*

FDA Label Image

Image (Genosyl Om 320)

A digital display screen showing a manual mode interface for dosing GENOSYL nitric oxide gas. It indicates 'READY' and 'DOSING' status bars on the left, with an illustration of an inhalation device and gas cylinder in the center. The right side shows estimated nitric oxide concentration at 20 ppm and a flow rate setting at 10 LPM, with arrow buttons for adjustment. Tabs for Main, Alarms, Calibration, Events, and Settings are visible at the bottom.*

FDA Label Image

Image (Genosyl Om 321)

An electronic device interface displaying settings for inhaled nitric oxide gas usage, labeled with manual mode controls and adjustable estimated NO concentration in parts per million (20 ppm shown). The display includes visual indicators for readiness, dosing, flow rate selection (10 LPM highlighted), and navigation icons for menu options like Main, Alarms, and Calibration.*

FDA Label Image

Image (Genosyl Om 322)

An instructional screen display showing a dosing system setup for GENOSYL nitric oxide gas inhalation. The interface indicates manual mode with indicators for dosing and readiness, an estimated NO concentration of 20 ppm, and a flow rate of 10 LPM. The screen includes tabs for Main, Alarms, Calibration, Events, and Settings, with an arrow pointing to a 'Switch to Primary' option.*

FDA Label Image

Image (Genosyl Om 323)

An instructional digital interface showing a prompt to confirm switching to a primary nitric oxide dosing at 20 ppm. The image includes a graphical representation of a nitric oxide gas delivery device on the left, with a highlighted 'Confirm' button circled in red and a 'Cancel' button on the right, implying user interaction for dosing adjustment.*

FDA Label Image

Image (Genosyl Om 324)

An electronic interface display illustrating primary mode settings for nitric oxide (NO) delivery. It shows a NO level of 20 ppm, a target NO set at 20 ppm, with additional values for NO2 at 0.1 ppm and oxygen concentration at 21%. The interface includes sections labeled Main, Alarms, Calibration, Events, and Settings, indicating a control panel for respiratory gas administration.*

FDA Label Image

Image (Genosyl Om 325)

An electronic display panel showing the control interface for administering inhaled nitric oxide (NO) gas. The screen highlights a set target NO concentration of 20 ppm, current NO level of 20 ppm, nitrogen dioxide (NO₂) of 0.1 ppm, and oxygen (O₂) at 21%. It includes interactive buttons for Main, Alarms, Calibration, Events, and Settings, with ‘Dosing’ and ‘Ready’ status indicators on the left.*

FDA Label Image

Image (Genosyl Om 326)

An electronic device screen displaying 'Primary Mode' operation for nitric oxide (NO) delivery with a dosing module showing NO at 20 ppm and NO2 at 0.0 ppm. The interface includes a keypad for entering target NO levels (0 to 80 ppm) with a red arrow pointing to the 'OK' button for confirmation.*

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Image (Genosyl Om 327)

An instructional display screen for a device related to GENOSYL (nitric oxide gas inhalation). The screen shows system configuration details including scheduled service due date, current date and time, and manual mode flow rate. Highlighted items indicate the 'Shutdown' option and the 'Settings' menu button, with arrows guiding the user's attention.*

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Image (Genosyl Om 328)

An instructional screen titled SHUTDOWN showing steps to confirm the shutdown of a dosing console. It indicates that dosing will stop, cassettes will eject, and instructs to save the right cassette for future use and dispose of the left cassette. A red arrow points to a highlighted Confirm button at the bottom left.*

FDA Label Image

Image (Genosyl Om 329)

The image shows the GENOSYL DS device used for delivering GENOSYL nitric oxide gas at a concentration of 0.98 mg/L via respiratory inhalation. The device is labeled GENOSYL DS, equipped with control buttons, a display screen, and two orange gas cylinders on the right side. The labeler is VERO BIOTECH, INC.*

FDA Label Image

Image (Genosyl Om 330)

GENOSYL 0.98 mg/L nitric oxide gas delivery system by VERO BIOTECH, INC. The image shows a medical device with a screen labeled GENOSYL DS, various control knobs and ports on the left side, and a hand inserting or removing an orange cartridge on the right, intended for respiratory inhalation use.*

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Image (Genosyl Om 331)

An illustration showing a hand operating a control or connection point on a medical device used for gas delivery, likely related to GENOSYL nitric oxide inhalation gas. The device is secured with a strap and has an electrical connection.*

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Image (Genosyl Om 332)

An electronic device screen displaying system configuration and operational controls for a medical device, with a red arrow pointing to a 'Settings' button at the bottom right. The interface includes status indicators, manual mode settings, and options related to dosing and leak testing.*

FDA Label Image

Image (Genosyl Om 333)

Screenshot of a medical device user interface screen labeled 'SHUTDOWN' showing operational status and configuration details. The screen highlights a section labeled 'Unit of Transport Mode (XXX/h)' circled in red, with other menu options including 'Main,' 'Alarms,' 'Calibration,' 'Events,' and 'Settings.' The device appears to offer monitoring and operational functions related to respiratory or gas delivery systems.*

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Image (Genosyl Om 334)

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Image (Genosyl Om 335)

An instructional interface screen labeled with several function buttons such as Main, Alarm, Events, and Settings. The screen shows a numeric keypad for PIN input, with the 'OK' key highlighted below the keypad. Additional text and icons indicate system operational modes and access controls, suggesting it is part of a control or monitoring device interface.*

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Image (Genosyl Om 336)

Illustration showing a digital display panel for a medical device used with GENOSYL nitric oxide gas. The screen indicates 'Primary Mode' with visual prompts to replace two red-labeled components and an instruction to 'Insert Cassette.' A menu option and status indicators including NO levels are visible.*

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Image (Genosyl Om 337)

GENOSYL nitric oxide gas inhalation system by VERO BIOTECH, INC. The image shows a dual-device medical system on a wheeled stand, featuring two GENOSYL DS units with digital screens and control panels, designed for respiratory administration of nitric oxide gas.*

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Figure 30 (Genosyl Om 338)

Illustration of the GENOSYL nitric oxide gas injection assembly connected to an anesthesia gas machine. The diagram labels components including the gas injection adapter, inline breathing circuit filter, vent ports, calibration port, manual ventilation bag connector, and tubing connections. Included is a key for VERO-provided accessories showing manual ventilation, NO dosing and injection lines, sample line, and DS ventilator circuit components.*

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Figure 31 (Genosyl Om 339)

Illustration showing the assembly and connection of the GENOSYL (nitric oxide) gas delivery system integrated with an anesthesia gas machine. The diagram labels key components including the mixer assembly with adaptive sensor, GENOSYL port, water trap, manual ventilation NO dosing port, calibration and adaptive sensor ports, oxygen tubing, manual ventilation bag adapter, gas sample tee, anesthesia machine, ventilation drive gas, bellows assembly, inspiratory and expiratory tubing and ports, heat moisture exchanger (optional), inline breathing circuit filter, and absorber. Color-coded lines indicate manual ventilation NO dosing, NO injection, NO sample, adaptive sensor, and GENOSYL DS ventilator circuit components.*

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Image (Genosyl Om 340)

An illustration diagram depicting a gas flow system with labeled components: an Adaptive Sensor, a Gas Injection Adapter (22mm ID x 22mm OD), and an Inline Breathing Circuit Filter. The diagram visually represents connections relevant to the delivery or administration of gas, consistent with respiratory inhalation systems.*

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Image (Genosyl Om 341)

An illustration showing a section of respiratory medical equipment with a focus on a component circled in red. This component appears to be part of a gas delivery system, including tubing and connectors, likely related to the administration of inhaled nitric oxide.*

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Image (Genosyl Om 342)

An instructional diagram illustrating a component of a respiratory inhalation system for gas delivery. The image highlights a part of the apparatus connecting a gas source to tubing, possibly showing a valve or connector assembly involved in administering GENOSYL (nitric oxide) gas. Various elements such as tubing, connectors, and control mechanisms are included, suggesting its use in the inhalation route of administration.*

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Image (Genosyl Om 343)

An instructional diagram showing a respiratory gas delivery setup labeled 'To Patient.' It features a flexible corrugated tube connected to a fitting at the top and a side port circled in red, indicating a connection or measurement point approximately 1/2 inch (12 mm) below the junction.*

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Image (Genosyl Om 344)

An instructional diagram illustrating part of a respiratory gas delivery system. It shows a gas reservoir bag connected to a device with a wheel or dial for adjusting flow or pressure, and tubing arranged for gas inhalation, likely related to nitric oxide delivery.*

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Image (Genosyl Om 345)

Illustration showing a component of a gas delivery system with a red oval highlighting a specific valve or connector. The depicted setup includes connectors, tubing, and a green bag, likely representing part of an inhalation gas system for respiratory use.*

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Image (Genosyl Om 346)

An illustration showing the components for administering GENOSYL nitric oxide gas via respiratory inhalation. It depicts an injection adapter labeled 22mm ID x 22mm OD connected to an NO injection port, with a red NO injection line extending outward, indicating the flow path for the gas delivery.*

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Image (Genosyl Om 347)

An instructional diagram showing a gas sampling setup for inhalation therapy. It depicts a gas sample tee connected to a sampling port with a Luer-Lock collar attaching the sample line. The diagram illustrates the flow direction of the gas through the system, relevant for respiratory intake of nitric oxide gas.*

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Image (Genosyl Om 348)

Illustration diagram showing a three-step process involving a vertical gas flow device and an attached gray rectangular component. Arrows indicate the movement and attachment of the gray component onto the device, demonstrating assembly or operational connections.*

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Image (Genosyl Om 349)

GENOSYL nitric oxide gas inhalation device by VERO BIOTECH, INC. The image shows the GENOSYL DS system equipped with dual control units mounted on a mobile wheeled stand, used for delivering nitric oxide gas at 0.98 mg/L for respiratory treatment.*

FDA Label Image

Image (Genosyl Om 350)

Illustration of a medical device display screen for GENOSYL nitric oxide gas inhalation therapy, showing the primary mode with current NO concentration (56 ppm), target NO concentration set at 20 ppm, NO2 concentration at 0.0 ppm, and an alarm banner with alarm icon in red at the top right. The screen includes navigation tabs for Main, Alarms, Calibration, Events, and Settings.*

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Image (Genosyl Om 351)

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Image (Genosyl Om 352)

A graph illustrating a plot of concentration over time for a respiratory gas product, possibly nitric oxide. The x-axis appears to represent time in seconds, with a point marked at 117 seconds. The y-axis represents an unspecified variable, likely concentration or dosage. The graph uses blue and white color schemes with a central triangular marker where the 117-second point is highlighted.*

FDA Label Image

Image (Genosyl Om 353)

FDA Label Image

Image (Genosyl Om 354)

Label for GENOSYL nitric oxide gas inhalation, showing a red circular design with '110 s' in white text on a blue background. The image suggests a timer or related measurement but does not display further product details.*

FDA Label Image

Figure 32 (Genosyl Om 355)

A troubleshooting menu screen displaying four main alert options: Low NO, Line Occlusion, Delivery Flow Error, and High Back Pressure, along with an Exit button at the bottom left. The screen includes indicators for battery level, a manual switch option, and a sound alert icon at the top.*

FDA Label Image

Figure 33 (Genosyl Om 356)

An on-screen troubleshooting guide for the GENOSYL nitric oxide gas delivery system by VERO BIOTECH, INC. The display instructs users to confirm proper line placement and retighten dosing and sample line connections. It asks if retightening resolved the issue and shows nitric oxide (NO) and nitrogen dioxide (NO2) concentration readings at 0.1 ppm and 0.0 ppm respectively, with navigation buttons for 'Exit', '< Back', 'Yes', and 'No'.*

FDA Label Image

Figure 34 (Genosyl Om 357)

A troubleshooting screen from the GENOSYL nitric oxide respiratory gas system showing an instruction to switch to the backup console if issues continue. The screen displays a low NO (lines reversed) alert, technical support contact number, current NO and NO2 levels at 0.0 ppm, and buttons for Exit, Back, and Accept.*

FDA Label Image

Image (Genosyl Om 358)

A warning screen titled 'NITRIC OXIDE DELIVERY INTERRUPTED' in white text on a blue background. The message in red and white text alerts that nitric oxide exceeded the maximum limit of 100 ppm, instructs to check the patient respiratory circuit for flow disruption, and states dosing will resume once nitric oxide is below 30 ppm. It advises switching to the back-up console and contacting technical support if the problem persists. A button labeled 'Accept' appears at the bottom.*

FDA Label Image

Image (Genosyl Om 359)

A text panel with a prominent red heading labeled 'High NO,' likely indicating information related to nitric oxide concentration or safety. The panel background is white, with the red header drawing attention to this section of the drug information for GENOSYL gas, nitric oxide inhalation by Vero Biotech.*

FDA Label Image

Image (Genosyl Om 360)

This image shows a digital display screen from a medical device used for monitoring nitric oxide (NO) levels in respiratory therapy. It indicates that the NO concentration is greater than 99 parts per million (ppm) and the NO2 concentration is 0.0 ppm. The display includes status indicators labeled "READY," menu tabs for Main, Alarms, Calibration, Events, and Settings, and a note about auto-resuming at 20 ppm after NO falls below 30 ppm.*

FDA Label Image

Image (Genosyl Om 361)

A warning screen titled 'NITRIC OXIDE DELIVERY INTERRUPTED' in white text on a blue background. The main message in a red box alerts that NO2 has exceeded the maximum limit of 3 ppm and instructs to check the patient respiratory circuit for flow disruption. It indicates dosing will resume once NO2 is below 3 ppm and advises switching to the backup console and contacting technical support if the problem persists.*

FDA Label Image

Image (Genosyl Om 362)

A red banner with the white text 'High NO2' prominently displayed, indicating a warning or caution related to nitrogen dioxide (NO2) presence in the context of the product or its usage.*

FDA Label Image

Image (Genosyl Om 363)

A digital display screen showing monitoring information for nitric oxide (NO) levels, with indicators for two gas cylinders labeled 'R' and 'R', both marked as 'READY'. The screen prominently displays NO concentration at 19 ppm and NO2 concentration greater than 3 ppm. Additional text includes an auto-resume setting for NO levels and navigation tabs at the bottom for Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 364)

This image shows a red banner with white text stating 'High NO,' likely indicating a warning or important note related to nitric oxide content, associated with the prescription drug GENOSYL (nitric oxide gas inhalation). The image highlights a caution or alert regarding nitric oxide levels.*

FDA Label Image

Image (Genosyl Om 365)

An electronic device display illustrating the dosing and readiness status of GENOSYL nitric oxide gas for respiratory inhalation. The screen shows a high NO (nitric oxide) level with NO concentration at 56 ppm, target NO set at 20 ppm, zero NO₂ and O₂ percentages, and menu options including Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 366)

FDA Label Image

Image (Genosyl Om 367)

Display screen of a nitric oxide (NO) delivery device showing Primary Mode with NO concentration at 20 ppm and a Target NO set at 20 ppm. Panels indicate dosing and ready status. Additional readings include NO2 level at 2.9 ppm and oxygen concentration at 21%. Navigation tabs for Main, Alarms, Calibration, Events, and Settings are visible at the bottom.*

FDA Label Image

Image (Genosyl Om 368)

An instructional or technical illustration showing three status indicators for a device: 'Low NO', 'Low NO (Line Disconnect)', and 'Low NO (Lines Reversed)', each highlighted with a red background. The image likely relates to alerts or error states associated with nitric oxide supply or delivery equipment.*

FDA Label Image

Image (Genosyl Om 369)

A screen display indicating that calibration is required for a device. It alerts that the console has not completed calibration and instructs to perform gas calibration including Air Calibration, High NO Calibration, and High NO2 Calibration. An 'Accept' button is shown at the bottom of the screen.*

FDA Label Image

Image (Genosyl Om 370)

A text panel with three separate lines of white text on a red background, each stating 'Cal Required' followed by a distinct term in parentheses: (Air), (NO), and (NO2). This likely refers to calibration requirements for specific gases or conditions.*

FDA Label Image

Image (Genosyl Om 371)

FDA Label Image

Image (Genosyl Om 372)

FDA Label Image

Image (Genosyl Om 373)

An alert screen titled 'HARDWARE FAILURE' displays a red notification box instructing to switch to the back-up console and to contact technical support at the provided phone number. The screen includes a 'Continue' button at the bottom.*

FDA Label Image

Image (Genosyl Om 374)

FDA Label Image

Image (Genosyl Om 375)

A digital screen showing a 'SERVICE REQUIRED' message in white text on a blue background, with additional instructions to contact Technical Support at 1-877-337-4118 displayed in white text on a red background. A gray 'Continue' button appears at the bottom of the screen.*

FDA Label Image

Image (Genosyl Om 376)

FDA Label Image

Image (Genosyl Om 377)

An instructional or anatomical figure titled 'Line Occlusion (Sample)', showing a diagram likely related to respiratory line occlusion procedures or concepts. The image contains a red header with white text and a central illustration demonstrating the occlusion mechanism.*

FDA Label Image

Image (Genosyl Om 378)

FDA Label Image

Image (Genosyl Om 379)

A warning screen displaying a 'CASSETTE REMOVED' alert with the date and time stamp 2023-11-28 12:01:08 PM. The message indicates that the left cassette was removed while dosing and instructs to switch to the backup console. There is an 'Accept' button below the message on the screen.*

FDA Label Image

Image (Genosyl Om 380)

A text panel titled 'WATER TRAP' instructing to connect or replace the Water Trap, with a prominent red background area and a 'Continue' button below the text.*

FDA Label Image

Image (Genosyl Om 381)

An instructional illustration showing a water trap disconnected from equipment, labeled with the red text 'Water Trap Disconnected.' This image likely serves as a visual alert or guideline related to the use or maintenance of respiratory gas equipment.*

FDA Label Image

Image (Genosyl Om 382)

A technical support message panel displaying a 'SERVICE REQUIRED' alert in blue header, a red box instructing to contact technical support at phone number 1-877-337-4118, and a gray 'Continue' button below the red box.*

FDA Label Image

Image (Genosyl Om 383)

A digital display screen showing a "SERVICE REQUIRED" message in white text on a blue background, with a red box below directing to contact technical support at 1-877-337-4118. A gray "Continue" button is visible at the bottom center of the screen.*

FDA Label Image

Image (Genosyl Om 384)

An instructional or alert screen displaying a 'SERVICE REQUIRED' message in white text on a red background. It advises contacting technical support at phone number 1-877-337-4118, with a 'Continue' button below the message.*

FDA Label Image

Image (Genosyl Om 385)

FDA Label Image

Image (Genosyl Om 386)

The image shows a device screen displaying an error message in white and red text on a blue background, stating "CASSETTE NOT OPERATIONAL" and instructing to switch to the back-up console. The message is timestamped 2023-08-09 10:24:37 AM and includes an "Accept" button below the text.*

FDA Label Image

Image (Genosyl Om 387)

A screen displaying a calibration failure error message for a device, indicating that air calibration failed on a specific date and time. Instructions are provided to repeat air calibration or contact technical support if the problem persists, with a phone number. There is an 'Accept' button below the message.*

FDA Label Image

Image (Genosyl Om 388)

A red error message screen indicating calibration failure for a device related to nitric oxide. The message states the date and time of failure and instructs the user to verify the calibration gas and contact technical support if the problem persists. The background is blue with an "Accept" button at the bottom.*

FDA Label Image

Image (Genosyl Om 389)

A device screen showing a red error message indicating 'CALIBRATION FAILED' for NO2 Calibration, with instructions to ensure correct calibration gas use, switch to Back-up Console if problem persists, and contact Technical Support.*

FDA Label Image

Image (Genosyl Om 390)

A software alert screen indicating a hardware failure related to dosing control for a respiratory drug delivery system. The message states that dosing change is not permitted due to hardware failure and instructs switching and confirming dosing on the back-up console before stopping dosing on the current console. The alert includes an 'Accept' button at the bottom.*

FDA Label Image

Image (Genosyl Om 391)

FDA Label Image

Image (Genosyl Om 392)

An alert screen showing a hardware failure message instructing the user that dosing modes cannot be switched due to hardware failure and advising switching to the back-up console, with a technical support phone number displayed. The screen includes a blue header, red alert box, and an 'Accept' button at the bottom.*

FDA Label Image

Image (Genosyl Om 393)

A drug facts or warning panel with a prominent red header stating "Hardware Failure." The panel likely addresses issues related to device malfunction but exact details are not legible in the image.*

FDA Label Image

Image (Genosyl Om 394)

A text panel displaying a highlighted yellow box with the words 'Low Battery.' No additional drug information is visible in the image.*

FDA Label Image

Image (Genosyl Om 395)

A device screen displaying a warning message that the right cassette is not operational, with instructions to replace it and indicating dosing continues with the left cassette. The screen shows a timestamp of August 9, 2023, 10:23:41 AM and an 'Accept' button for user acknowledgment.*

FDA Label Image

Image (Genosyl Om 396)

An electronic display screen showing a service notice for the GENOSYL inhalation gas product. The message states that the service due date has expired as of 2023-07-11 and advises contacting Technical Support at the provided phone number to schedule service. There is an 'Accept' button below the message.*

FDA Label Image

Image (Genosyl Om 397)

Instructional screen displaying a low fuel warning for the left cassette in a device, advising that the left cassette will deplete within one hour and instructing to insert a cassette into the right cassette receptacle. Features a yellow warning box with blue and white text and an 'Accept' button at the bottom.*

FDA Label Image

Image (Genosyl Om 398)

A highlighted section labeled 'Low O2' in yellow. The text appears to be part of a drug facts or instruction panel related to oxygen levels, likely associated with GENOSYL, nitric oxide gas for respiratory inhalation at a strength of 0.98 mg/L by Vero Biotech, Inc.*

FDA Label Image

Image (Genosyl Om 399)

Text panel header showing the words "High O2" highlighted in yellow, likely indicating oxygen concentration or related inhalation instructions for the respiratory gas product GENOSYL (nitric oxide). No additional text is visible in this excerpt.*

FDA Label Image

Image (Genosyl Om 400)

A drug facts or alert message panel displaying a Nitric Oxide delivery error. The message states that the main pump has failed, but the console will continue working with the backup pump. It also provides a technical support contact number (1-877-337-4118) and an 'Accept' button below the text.*

FDA Label Image

Image (Genosyl Om 401)

A text panel titled "Delivery Flow Error" in black text on a yellow highlight background. It appears to be a part of an instructional or cautionary notice related to delivery flow issues, without additional detail visible.*

FDA Label Image

Image (Genosyl Om 402)

An instructional screen showing a high back pressure warning for a medical device. The message advises inspection of gas lines and respiratory circuits for kinks or occlusions and provides a technical support contact number for further assistance. Includes a 'Continue' button at the bottom.*

FDA Label Image

Image (Genosyl Om 403)

A highlighted text panel section titled 'High Back Pressure,' likely part of a safety or usage instructions panel related to the GENOSYL nitric oxide inhalation gas product.*

FDA Label Image

Image (Genosyl Om 404)

An instructional screen displaying a warning message titled 'INCORRECT CASSETTE TYPE' in white text on a blue background, over a yellow text box with black text. It advises that External Transport Mode is off and instructs to turn it on or insert a blue hospital cassette to dose. Also provides a technical support phone number and features an 'Accept' button below the message.*

FDA Label Image

Image (Genosyl Om 405)

An error message screen titled "INCORRECT CASSETTE TYPE" warning that External Transport Mode is ON, instructing the user to turn it off or insert an ORANGE External Transport Cassette to dose. It provides a technical support phone number and has an "Accept" button below the message.*

FDA Label Image

Image (Genosyl Om 406)

A drug facts or informational text panel titled 'Nitric Oxide Delivery Interrupted.' It advises that flow is not detected through the Adaptive Sensor, instructs checking the patient respiratory circuit for flow disruption, notes dosing will resume once flow is restored, and recommends switching to the backup console and contacting technical support if the problem persists. Includes an 'Accept' button at the bottom.*

FDA Label Image

Image (Genosyl Om 407)

A digital display screen showing respiratory gas monitoring parameters for nitric oxide (NO) with a reading of 0.10 ppm and nitrogen dioxide (NO2) at 0.0 ppm. The screen includes status indicators, such as 'READY' in green and 'REPLACE' in red, and a notification for auto-resume at 20 ppm after flow is restored. The display likely pertains to equipment used for administering or monitoring inhaled nitric oxide.*

FDA Label Image

Image (Genosyl Om 408)

An electronic display screen showing a warning message: 'EXTERNAL POWER DISCONNECTED.' Below it, the message states 'Console running on battery. Connect the A/C Power Adapter.' There is a rectangular "Accept" button at the bottom center of the screen.*

FDA Label Image

Image (Genosyl Om 409)

A digital screen notification displaying a service due date message. The message indicates that service is due within 2 days, with a specific date provided, and includes a technical support contact number. The screen has a blue background with black text and an "Accept" button at the bottom.*

FDA Label Image

Image (Genosyl Om 410)

A digital alert screen titled "CALIBRATION DUE" listing high calibration reminders within 48 hours for NO2, NO, and O2. The screen has a blue background with white text and a green box containing the detailed calibration due messages, along with an "OK" button at the bottom.*

FDA Label Image

Image (Genosyl Om 411)

A digital display screen showing a post message indicating a service due date within 14 days, specify service due on 2024-01-02. It advises contacting Technical Support at a provided phone number to schedule the service, with an 'Accept' button visible at the bottom.*

FDA Label Image

Image (Genosyl Om 412)

This image shows a device screen warning with the header 'LEFT CASSETTE LOW FUEL' in white text on a blue background. The message in green background text informs that the left cassette will deplete within two hours and instructs to insert a cassette into the right cassette receptacle. There is an 'Accept' button at the bottom center in gray.*

FDA Label Image

Image (Genosyl Om 413)

A digital screen display showing a calibration alert message for GENOSYL nitric oxide gas. The message states that NO2 High Calibration and NO High Calibration and O2 High Calibration are expired, and asks whether to skip the calibration for 24 hours, with options to select Yes or No.*

FDA Label Image

Image (Genosyl Om 414)

FDA Label Image

Image (Genosyl Om 415)

A digital screen prompt asking whether to turn ON External Transport Mode, warning that doing so requires an External Transport password. Two selectable options are shown at the bottom: Confirm and Cancel. The screen uses green, orange, and white text on a green background.*

FDA Label Image

Image (Genosyl Om 416)

An instruction or warning screen prompt asking if the user would like to turn off External Transport Mode, indicating that doing so requires the External Transport password. The screen includes 'Confirm' and 'Cancel' buttons for user response.*

FDA Label Image

Image (Genosyl Om 417)

Screenshot of an electronic display showing a prompt titled 'External Transport Mode.' The message states that a cassette cannot be present in the console while switching External Transport Mode and asks if the user would like to eject the current cassette. There are two buttons labeled 'Eject' and 'Cancel.'*

FDA Label Image

Image (Genosyl Om 418)

A screen panel titled 'External Transport Mode' displaying an error message advising that the external transport mode cannot be switched while the left cassette is dosing. It instructs the user to set the dose to 0 ppm and try again, with an 'Accept' button shown below the message.*

FDA Label Image

Figure 35 (Genosyl Om 419)

A digital display screen showing alarm settings and status for respiratory gas monitoring. It displays lower and upper limits for NO (nitric oxide) in ppm, NO2 in ppm, and O2 in percentage. A prominent alert 'Leak Suspected' is visible, along with an alarm history detailing sensor issues and instructions to contact service. Menu options include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 420)

GENOSYL DS nitric oxide gas delivery system by VERO BIOTECH, INC. The image shows a dual-module respiratory inhalation device with two control units mounted on a wheeled stand, used for administering GENOSYL nitric oxide gas at the strength 0.98 mg/L. The device features screens, control knobs, and tubing connectors.*

FDA Label Image

Image (Genosyl Om 421)

A digital calibration interface screen for a respiratory gas analyzer showing measurement of gases including air, nitric oxide (NO), nitrogen dioxide (NO2), and oxygen (O2) levels. The display includes current readings, calibration dates, status indicators with green check marks, and menu options such as Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 422)

An electronic display screen showing a calibration confirmation message for air calibration, including the date and time the calibration passed, with an 'Accept' button beneath the message.*

FDA Label Image

Image (Genosyl Om 423)

A digital calibration screen showing settings for gases including Air, NO (nitric oxide), and NO2, with values set to zero ppm and O2 set at 21.0%. The panel displays calibration due dates for each gas and checkmarks indicating a completed status. Buttons for Start Calibration, Main, Alarms, Calibration, Events, and Settings are visible.*

FDA Label Image

Image (Genosyl Om 424)

An instructional diagram titled 'CALIBRATION' showing how to connect a 45 ppm Nitric Oxide (NO) calibration cylinder to the calibration port by uncovering the port, opening the valve, and pressing OK to start the process.*

FDA Label Image

Image (Genosyl Om 425)

A digital display screen showing a calibration confirmation message for nitric oxide gas. It indicates that calibration passed on 2023-12-19 with instructions to close the valve from the Calibration Gas Tank and disconnect the tubing from the Calibration Port. A button labeled 'Accept' is visible below the message.*

FDA Label Image

Image (Genosyl Om 426)

A device display screen showing calibration settings and status for gases including Air, NO, NO2, and O2. The display includes measured gas concentrations in parts per million (ppm) for NO, NO2, and oxygen percentage, alongside calibration due dates and status indicators. The interface features tabs labeled Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Om 427)

An instructional calibration screen showing steps to calibrate using a Nitrogen Dioxide (10 ppm NO2) calibration cylinder. The image highlights the calibration port on a device and provides step-by-step prompts: uncover the port, connect the cylinder, open the valve, and press OK to start calibration.*

FDA Label Image

Image (Genosyl Om 428)

A digital screen showing a calibration confirmation message for nitric oxide (NO2) gas delivery equipment. The message states that NO2 calibration passed on December 19, 2023, at 12:38:30 PM, and instructs to close the valve from the Calibration Gas Tank and disconnect the tubing from the Calibration Port. The screen includes an "Accept" button at the bottom.*

FDA Label Image

Figure 36 (Genosyl Om 429)

Illustration showing a gas alarm mount assembly with two knobs and an attached metal basket below. A large red arrow points to the right side of the assembly, indicating a highlighted area marked with red dashed circles on both left and right panels.*

FDA Label Image

Image (Genosyl Om 430)

The image shows a GENOSYL DS device labeled with the VERO BIOTECH logo, featuring a display screen and control knobs. A hand is adjusting a blue knob on the front panel, indicating user interaction with the device likely related to nitric oxide gas administration.*

FDA Label Image

Image (Genosyl Om 431)

The image shows the GENOSYL DS device by VERO BIOTECH, INC., used for administering GENOSYL nitric oxide gas inhalation therapy. A hand is attaching or adjusting a small component or cartridge on the front left side of the device, which features a screen in the center and labeled controls. The device is primarily white with the labeler name visible.*

FDA Label Image

Image (Genosyl Om 432)

The image shows a medical device labeled GENOSYL DS by VERO BIOTECH, INC. A hand is adjusting a clear blue component on the left side of the device. The device features a black screen and various buttons and indicators, suggesting it is used for administering or controlling respiratory inhalation therapy.*

FDA Label Image

Image (Genosyl Om 433)

The image shows the front panel of a GENOSYL DS medical device by VERO BIOTECH, INC. This device is designed for the administration of GENOSYL (nitric oxide) gas via respiratory inhalation. The device features a screen and control knobs, with a hand adjusting one of the controls, indicating user interaction with this gas delivery system.*

FDA Label Image

Image (Genosyl Om 434)

GENOSYL DS nitric oxide gas inhalation device by VERO BIOTECH, INC. The image shows a medical device used for respiratory administration of nitric oxide, featuring a digital display, control knobs, and mounted on a mobile stand with wheels and a storage basket. This device relates to the GENOSYL product line.*

FDA Label Image

Figure 37 (Genosyl Om 435)

A line graph titled 'GENOSYL DS Cassette Output Range' showing the relationship between total flow (LPM) on the horizontal axis and nitric oxide delivered concentration (ppm) on the vertical axis. The graph features curves labeled 'Minimum Output' and 'Maximum Output' illustrating the output range of nitric oxide delivery across different flow rates from 0 to 120 LPM and concentration levels from 0 to 80 ppm.*

FDA Label Image

Image (Genosyl Om 436)

A data table listing various ventilation device manufacturers and models with recommended tidal volume ranges where a mixer is advised at 6 breaths per minute (BPM). The table includes columns for hospital use and external transport use, with certain cells marked 'N/A' or blacked out to indicate limitations or non-validation for external transport mode.*

FDA Label Image

Image (Genosyl Om 437)

The image shows the GENOSYL DS system by VERO BIOTECH, featuring two identical control units labeled GENOSYL DS mounted on a mobile stand with wheels. Each unit has a screen and various control knobs and ports. The system is designed for delivering nitric oxide gas for human prescription use via respiratory inhalation.*

FDA Label Image

Image (Genosyl Om 438)

FDA Label Image

Image (Genosyl Om 439)

A full view of the GENOSYL DS device by VERO BIOTECH. The image shows the dual-module respiratory inhalation system for nitric oxide delivery, mounted on a rolling stand with caster wheels. Each module has a touchscreen display and control interface, connected by a central support with a basket for accessories.*

FDA Label Image

Image (Genosyl Qrg 01)

GENOSYL DS device used for administering nitric oxide gas via respiratory inhalation. The front panel features a digital display screen showing system status and settings, with labeled buttons for main, alarms, calibration, events, and settings. There are two cartridge compartments on the right side, with visible cartridge labels. The device is primarily white with various connectors and indicators on the left side. Labeler is VERO BIOTECH, INC.*

FDA Label Image

Figure 1 (Genosyl Qrg 02)

Illustration of a GENOSYL DS device by Vero Biotech, Inc., used for administering nitric oxide gas (0.98 mg/L) via respiratory inhalation. The labeled diagram identifies components including the silver power button, battery charge indicator, nitric oxide (NO) delivery port, water trap with gas sample port, calibration port, manual ventilation port, adaptive sensor port, dual cassettes, and cassette access door. The device features a digital display screen showing primary mode settings.*

FDA Label Image

Figure 2 (Genosyl Qrg 03)

Illustration of the GENOSYL DS device front panel showing labeled indicators and controls for nitric oxide delivery. Labels identify battery charge status, adaptive sensor, mode switch button, console mode, measured NO dose, target NO dose, menu tab, dual cassette status, NO2 measured level, and O2 measured level. The screen displays NO and O2 levels and target settings for respiratory inhalation use.*

FDA Label Image

Figure 3 (Genosyl Qrg 04)

Diagram of the GENOSYL nitric oxide gas administration system showing labeled components and connections, including injection assembly with adaptive sensor, gas ports, ventilator circuit parts, oxygen tubing, and sensors used for respiratory inhalation delivery in a medical setting.*

FDA Label Image

Figure 4 (Genosyl Qrg 05)

An instructional diagram illustrating the assembly and components of the GENOSYL nitric oxide gas delivery system by Vero Biotech, Inc. The image labels parts including the mixer assembly with adaptive sensor, nitrogen oxide port, ventilation ports, oxygen tubing, manual ventilation bag adapter, humidifier, and temperature probe, providing a detailed overview of the respiratory inhalation gas device setup.*

FDA Label Image

Figure 5 (Genosyl Qrg 06)

Illustration showing the assembly of the GENOSYL nitric oxide gas delivery system with labeled components. Key parts include the injection assembly with adaptive sensor, GENOSYL port, calibration port, water trap, manual ventilation NO dosing port, oxygen tubing, manual ventilation bag adapter and connector, stopcock, Optiflow Jr adapter and cannula, various adapters, humidifier, air/oxygen blender, and flowmeter. Flow lines for manual ventilation, NO injection, NO sampling, and sensor cables are color-coded in black, red, blue, and gray respectively.*

FDA Label Image

Figure 6 (Genosyl Qrg 07)

Illustration diagram showing the assembly of the GENOSYL (nitric oxide) gas delivery system with Adaptive Sensor. The labeled components depict connections and parts such as the injection assembly, ports for sensors and calibration, water trap, manual ventilation adapters, oxygen tubing, humidifier, air/oxygen blender, and flowmeter, detailing the respiratory inhalation setup for administering nitric oxide gas at .98 mg/L strength by VERO BIOTECH, INC.*

FDA Label Image

Figure 7 (Genosyl Qrg 08)

Illustration diagram showing the assembly sequence for gas flow components related to nitric oxide administration. It features an Adaptive Sensor, a Gas Injection Adapter (22mm ID x 22mm OD), and an Inline Breathing Circuit Filter connected in series, depicting gas flow direction from the sensor through the adapter to the filter.*

FDA Label Image

Figure 8 (Genosyl Qrg 09)

An instructional diagram depicting the assembly of a gas delivery system for inhalation. The image shows components connected in series including an Adaptive Sensor, Injection Adapter, a central Mixer labeled with 'Gas Flow' arrows, Adapter, and an Inline Breathing Circuit Filter. Key connectors and directions are labeled as proximal and distal points.*

FDA Label Image

Image (Genosyl Qrg 10)

Photograph showing a hand connecting or adjusting a cable or sensor on the front panel of a GENOSYL DS medical device, used for delivering nitric oxide gas by respiratory inhalation. The device is white with labeled controls and ports, including a black screen area.*

FDA Label Image

Image (Genosyl Qrg 11)

An image showing a close-up of a GENOSYL DS device by Vero Biotech, used for delivering nitric oxide gas. A hand is interacting with the device's front panel, specifically adjusting a small clear chamber with attached tubing, highlighted by a red circle. The device is designed for respiratory inhalation of nitric oxide.*

FDA Label Image

Image (Genosyl Qrg 12)

A close-up image of a medical device labeled GENOSYL DS by VERO Biotech, showing a hand connecting a tube to one of the device's ports. This device is associated with delivering nitric oxide gas, used for respiratory inhalation therapy.*

FDA Label Image

Image (Genosyl Qrg 13)

The image shows a person’s hand connecting a tubing or sensor to a medical device labeled GENOSYL DS by Vero Biotech. The device appears to be related to the inhalation delivery system for GENOSYL (nitric oxide) gas, used in respiratory treatment. The connection point is highlighted with a red circle.*

FDA Label Image

Image (Genosyl Qrg 14)

User interface screen from a medical device displaying dosing information for GENOSYL nitric oxide gas. The screen shows primary mode dosing with nitric oxide (NO) concentration at 20 ppm, target NO set at 20 ppm, nitrogen dioxide (NO2) at 0.0 ppm, and oxygen (O2) at 21%. The interface includes status indicators and menu tabs for main, alarms, calibration, events, and settings.*

FDA Label Image

Image (Genosyl Qrg 15)

An illustration showing components of a respiratory inhalation gas delivery system for GENOSYL (nitric oxide). The image includes tubing with connectors, a blue valve, and a white adapter piece. The tubing and connectors appear designed for controlled gas flow in a medical setting.*

FDA Label Image

Image (Genosyl Qrg 16)

GENOSYL, nitric oxide gas for respiratory (inhalation) use, is shown with two flexible tubing components and a clear plastic valve device. One tubing is red with a connector, the other is clear with a blue stripe and connector. The valve has a blue control element and a clear grip handle. Labeler VERO BIOTECH, INC. is associated with the product.*

FDA Label Image

Image (Genosyl Qrg 17)

GENOSYL nitric oxide gas delivery set featuring clear tubing with connectors at both ends and a control valve. The image shows the device components used for respiratory inhalation administration, labeled with VERO BIOTECH, INC. branding.*

FDA Label Image

Image (Genosyl Qrg 18)

A digital interface display showing manual mode control for dosing gas, specifically nitric oxide. It includes indicators labeled "READY" and "DOSING" on green bars, an estimated nitric oxide concentration of 20 ppm, and a flow rate setting of 10 LPM. The screen also has menu options labeled Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Qrg 19)

An instructional diagram showing the setup for GENOSYL nitric oxide gas administration. It depicts an injection adapter labeled with dimensions (22 mm ID x 22 mm OD), connected to an NO injection port, from which extends an NO injection line. The illustration visually explains connection components for respiratory inhalation delivery.*

FDA Label Image

Image (Genosyl Qrg 20)

An illustration showing a respiratory gas flow system with a stopcock valve marked as open and a sample line attached. Blue arrows indicate the direction of gas flow through the valve and tubing, likely representing inhalation gas delivery.*

FDA Label Image

Image (Genosyl Qrg 21)

Illustration showing three steps for attaching a rectangular device to a pipe or tube system using a clip mechanism. The device is positioned beside the pipe, then clipped around it, demonstrating how it securely fastens in place.*

FDA Label Image

Figure 9 (Genosyl Qrg 22)

An illustration diagram showing the assembly for administering GENOSYL nitric oxide gas via respiratory inhalation. The diagram includes labeled components such as Oxygen Source, Oxygen Port, Oxygen Tubing, Manual Ventilation Bag NO Adapter, Manual Ventilation NO Dosing Line, and NO Injection Port. It also lists VERO provided accessories, including Manual Ventilation NO Dosing Line, GENOSYL DS Ventilator, and Circuit Components.*

FDA Label Image

Image (Genosyl Qrg 23)

An instructional diagram titled 'Water Trap / Sample Line Leak Test' showing a schematic of a respiratory gas line with a water trap component. The test checklist includes confirming if the test timed out, if the sample line was closed or connected properly, and if the water trap was seated and sealed correctly. The illustration includes a red status bar labeled 'Test FAILED' and a button labeled 'Accept.'*

FDA Label Image

Image (Genosyl Qrg 14a)

A digital device screen displaying respiratory gas monitoring information for nitric oxide (NO) therapy. The screen shows primary mode settings with NO concentration at 20 ppm, a target NO set value at 20 ppm, nitrogen dioxide (NO2) at 0.0 ppm, and oxygen (O2) at 21%. Indicators for device status include 'READY' and 'DOSING' on green bars. Navigation options are visible at the bottom, including Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Qrg 24)

Screenshot of a respiratory inhalation device display for GENOSYL (nitric oxide gas) showing primary mode settings. The interface indicates NO concentration at 56 ppm with a target of 20 ppm, accompanied by an alarm banner reading High NO and an alarm icon. Control tabs include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Qrg 25)

FDA Label Image

Image (Genosyl Qrg 26)

GENOSYL .98 mg/L nitric oxide gas for respiratory inhalation. The image shows a circular dial with a central icon and the number 117s highlighted in red, likely representing a timing or flow indicator related to the product's administration. The label is from VERO BIOTECH, INC.*

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Image (Genosyl Qrg 27)

FDA Label Image

Image (Genosyl Qrg 28)

FDA Label Image

Image (Genosyl Qrg 29)

The table lists manufacturers and models of respiratory devices alongside recommended tidal volume ranges for using a gas mixer at 6 BPM, differentiating between hospital use and external transport use. It includes tidal volume thresholds in milliliters and notes on device validation for external transport mode.*

FDA Label Image

Image (Genosyl Agm Qrg 01)

Illustration showing a hand connecting a hose or cable to the back panel of a medical or laboratory device with visible metal connectors and a safety warning label. The image depicts equipment setup or interaction, but no specific product branding or identifying text related to GENOSYL or nitric oxide gas is visible.*

FDA Label Image

Image (Genosyl Agm Qrg 02)

Illustration of a GENOSYL nitric oxide gas delivery device used for respiratory inhalation. The image shows a hand adjusting the device's control panel, which includes a display screen and various control knobs and connectors. The device is labeled with the brand name VERO.*

FDA Label Image

Image (Genosyl Agm Qrg 03)

The image shows a close-up of a GENOSYL DS medical device, labeled with the brand name and the manufacturer, VERO BIOTECH, INC. The device appears to be an inhalation delivery system for nitric oxide gas, with control knobs and a display screen visible.*

FDA Label Image

Image (Genosyl Agm Qrg 04)

Illustration showing a person connecting a tube to the GENOSYL OS device by VERO BIOTECH, INC., which is used for delivery of nitric oxide gas for respiratory inhalation. The device front panel and connection ports are visible.*

FDA Label Image

Image (Genosyl Agm Qrg 05)

An instructional diagram showing a respiratory gas delivery setup with labeled components including inspiratory port, adaptive sensor, adaptive sensor cable, gas injection adapter, red injection line connected to the gas injection adapter, and an inline breathing circuit filter. The illustration highlights the connection and flow within the breathing circuit.*

FDA Label Image

Image (Genosyl Agm Qrg 06)

Illustration showing a respiratory gas sampling setup for GENOSYL nitric oxide inhalation gas. The diagram labels a Gas Sample Tee, Luer-lock collar of Sample Line connected to the Sampling Port, and Inspiratory Limb tubing, with a dimensional indication between 6 and 12 inches.*

FDA Label Image

Image (Genosyl Agm Qrg 07)

An instructional diagram showing the setup for GENOSYL nitric oxide gas delivery. It depicts components including an oxygen source, oxygen port, oxygen tubing, manual ventilation bag NO adapter, manual ventilation NO dosing line, and NO injection port. The diagram highlights VERO-provided accessories for manual ventilation dosing and ventilator circuit components.*

FDA Label Image

Image (Genosyl Agm Qrg 08)

Illustration diagram showing the injection assembly setup for GENOSYL (nitric oxide) gas delivery system, including components such as adaptive sensor, NO gas injection adapter, inline breathing circuit filter, manual ventilation NO dosing port, and anesthesia gas machine. The diagram is labeled with accessory parts like oxygen tubing, manual ventilation bag adapter, heat moisture exchanger, and absorbers, detailing the respiratory inhalation delivery process.*

FDA Label Image

Image (Genosyl Agm Qrg 09)

GENOSYL 0.98 mg/L gas for respiratory inhalation by Vero Biotech, Inc. The image shows a label on a gas cylinder or container featuring the proprietary name GENOSYL and labeling indicating hospital use only. The label also includes the Vero Biotech logo on an attached metal plate.*

FDA Label Image

Image (Genosyl Agm Qrg 10)

The image shows the GENOSYL gas delivery device by Vero Biotech, Inc. It is used for the inhalation administration of nitric oxide at a strength of 0.98 mg/L. The device features a control panel with digital display and warning indicators, and a hand is seen interacting with a component on the right side of the unit.*

FDA Label Image

Image (Genosyl Agm Qrg 11)

An instructional diagram showing the setup for a water trap sample line leak test in a respiratory inhalation system. It depicts the positions of sample lines and valves, highlighting the step to close the stopcock located at the end of the sample line, with an indication that the test is in progress.*

FDA Label Image

Image (Genosyl Agm Qrg 12)

An electronic control panel screen showing monitoring of inhaled nitric oxide therapy. The display includes two green vertical status bars labeled 'READY,' a central numeric display for Target NO (ppm) set to zero, and menu tabs at the bottom labeled Main, Alarms, Calibration, Events, and Settings. The screen is primarily blue with white text.*

FDA Label Image

Image (Genosyl Agm Qrg 13)

Illustration of a medical device screen showing settings for GENOSYL (nitric oxide) gas inhalation. The screen displays two green cylinders labeled 'READY' and a numeric keypad interface on the right for entering concentrations, with the number 20 highlighted. Navigation tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Agm Qrg 14)

Illustration showing an electronic interface for entering a target nitric oxide (NO) value, set here at 20, with a keypad including numbers 0-9, a decimal point, and buttons labeled OK, Cancel, and Clear.*

FDA Label Image

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An instructional diagram showing a screen prompt titled 'Switch to Manual Dosing?' with options to 'Confirm' or 'Cancel.' The screen displays parameters related to nitric oxide dosing, including target NO levels and flow sensor readings, illustrating the manual dosing interface for a nitric oxide delivery system.*

FDA Label Image

Image (Genosyl Agm Qrg 16)

Illustration of a device interface for GENOSYL (nitric oxide) gas delivery system. The screen shows a manual mode with green status indicators labeled READY and DOSING, a graphical outline of the delivery apparatus, and displays estimated nitric oxide concentration (20 ppm) and flow rate (10 LPM). Navigation tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Agm Qrg 17)

An instructional diagram showing a medical device interface for inhalation dosing of nitric oxide. It features a green screen indicating primary dosing at 20 ppm, a dial labeled 'NO,' and control buttons labeled 'Confirm' and 'Cancel.' An orange oval highlights the 'Confirm' button.*

FDA Label Image

Image (Genosyl Agm Qrg 18)

Illustration showing a respiratory circuit with labeled expiratory and inspiratory lines. It highlights the location of a nebulizer distal from the inspiratory gas sample tee, used in the administration or monitoring of inhalation gases such as nitric oxide.*

FDA Label Image

Image (Genosyl Agm Qrg 19)

Illustration showing a respiratory gas delivery setup for GENOSYL, featuring a sample line with a sample line filter connected to an open stopcock valve, demonstrating part of the inhalation gas flow path.*

FDA Label Image

Image (Genosyl Agm Qrg 20)

Illustration of a medical device screen showing a primary mode respiratory interface for nitric oxide delivery. It features pressure and readiness indicators, a nitric oxide gas graphic symbol, and a target NO concentration setting of approximately 20 ppm with a flow rate below 2.5 LPM. The screen includes tab options for Main, Alarms, Calibration, Events, and Settings, with a highlighted 'Set' button for target NO adjustment.*

FDA Label Image

Image (Genosyl Agm Qrg 21)

An electronic device interface screen displaying dosing controls for inhalation gas flow. The screen shows a keypad for entering target values, numerical input of '20', and selection buttons for flow ranges: '< 2.5 LPM', '2.5 - 10 LPM', and '> 10 LPM'. Tabs at the bottom include Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Agm Qrg 22)

Illustration showing the GENOSYL DS inhalation gas delivery system by VERO BIOTECH, INC., featuring the control panel with adjustment knobs and display. A hand is adjusting the flow control on the device, used for administering nitric oxide gas at a strength of 0.98 mg/L via respiratory inhalation.*

FDA Label Image

Image (Genosyl Agm Qrg 23)

A digital control panel display for a nitric oxide (NO) inhalation device. It shows primary mode settings with NO concentration at 20 ppm, target concentration set to 20 ppm, NO2 concentration at 0.0 ppm, and oxygen level at 21%. A finger is pressing the button labeled 'Set' next to the target ppm control. The panel includes menu options such as Main, Alarms, Calibration, Events, and Settings.*

FDA Label Image

Image (Genosyl Agm Qrg 24)

An electronic device interface screen showing primary mode settings for gas dosing. The screen displays nitric oxide (NO) concentration at 20 ppm, nitrogen dioxide (NO2) at 0.0 ppm, and an alphanumeric keypad for input. Tabs for Main, Alarms, Calibration, Events, and Settings are shown at the bottom of the interface.*

FDA Label Image

Image (Genosyl Agm Qrg 25)

An instructional graphic showing the control panel interface for a GENOSYL nitric oxide inhalation gas device. The screen displays system configuration, scheduled service date, current date and time, manual mode flow settings, and external transport mode options. Navigation tabs including Main, Alarms, Calibration, Events, and Settings are visible at the bottom.*

FDA Label Image

Image (Genosyl Agm Qrg 26)

Illustration of a dosing console screen for GENOSYL nitric oxide gas inhalation product. The screen shows instructions for shutdown, including stopping dosing and ejecting cassettes. It highlights saving the right cassette for future use and disposing of the left cassette. Buttons to "Confirm" or "Cancel" the action are visible at the bottom.*

FDA Label Image

Image (Genosyl Agm Qrg 27)

Photograph of the GENOSYL DS device, a respiratory inhalation system for delivering nitric oxide gas at .98 mg/L strength. The image shows the front panel with a screen and various connectors, with a hand removing or inserting a cartridge or component on the right side. The device is labeled with the brand name GENOSYL DS and is manufactured by VERO BIOTECH, INC.*

FDA Label Image

Image (Genosyl Agm Qrg 28)

The image shows the GENOSYL DS inhalation device by Vero Biotech, Inc. It is a compact, rectangular respiratory gas delivery system labeled with the product name "GENOSYL DS" and the company's logo. A person's hand is adjusting a control on the front panel, which has buttons, knobs, and a display screen. The device is used for administering nitric oxide gas, notably the 0.98 mg/L strength in medical settings.*

FDA Label Image

Image (Genosyl Agm Qrg 29)

The image shows a GENOSYL DS inhalation gas device by VERO BIOTECH, INC. The front panel features control knobs, a display screen, and connection ports. The device is used for delivering nitric oxide gas at a strength of .98 mg/L via respiratory inhalation. The labeler name VERO BIOTECH appears on the right side of the unit.*

FDA Label Image

Image (Genosyl Agm Qrg 30)

FDA Label Image

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An illustration showing a water trap device with a message instructing to connect or replace the water trap. There is a prominent red box emphasizing this instruction, and a button labeled Continue below.*

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Image (Genosyl Agm Qrg 32)

An illustration banner displaying the text 'Water Trap Disconnected' in white font on a red background with a blue outline. A red alert bell icon with sound waves is shown on the right side of the banner, conveying a warning or alert message.*

FDA Label Image

Image (Genosyl Agm Qrg 33)

FDA Label Image

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Packaging label for GENOSYL, a nitric oxide gas for respiratory inhalation. The label prominently displays the text 'High NO' on a red background with a small logo on the right side, indicating high nitric oxide concentration. The label appears simple and focused on identifying the gas product.*

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Image (Genosyl Agm Qrg 35)

A red rectangular warning bar with the white text "High NO2" prominently displayed, indicating elevated nitrogen dioxide levels. This label is likely part of a safety or caution section related to the inhalation gas product GENOSYL (nitric oxide).*

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Principal Display Panel (216 L Cartridge Label)

GENOSYL nitric oxide gas for inhalation 0.98 mg/L label showing dosage instructions, lot number, serial number, and expiration date fields. The label specifies Rx only, 800 PPM strength, and storage instructions. It is manufactured by VERO Biotech, Inc., with a warning indicating use is for hospital only.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.