Hepzato Kit
Product Images NDC 75833-601

Product Visual Gallery

This gallery contains 50 technical images submitted to the FDA as part of the official labeling for Hepzato Kit (NDC 75833-601). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Delcath Systems, 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.

FDA Label Image

Figure (Hep11 0001 01)

Chemical structure diagram of melphalan hydrochloride, the active ingredient in Hepzato Kit. The diagram shows the molecular arrangement used in the lyophilized injection form provided for intra-arterial administration by Delcath Systems, Inc.*

FDA Label Image

Figure (Hep11 0001 02)

Instructions for use document cover for Hepzato Kit (melphalan) for Injection/Hepatic Delivery System (HDS) by Delcath Systems, Inc. The page displays the product name, generic name, and indicates it is instructional material.*

FDA Label Image

Figure (Hep11 0001 03)

An instructional diagram of the Hepzato Kit, showing the intra-arterial infusion system for melphalan hydrochloride. The illustration details the blood flow circuit with components labeled, including double balloon catheter, hemofiltration cartridges, venous return line with bubble trap, and flow probe. It depicts catheter placements in the human anatomy and the flow direction through the system for treatment administration.*

FDA Label Image

Figure (Hep11 0001 04)

Illustration of the Hepzato Kit components for intra-arterial administration, showing the hemofiltration circuit with filter inflow and outflow assemblies, hemofiltration cartridges, pressure monitoring lines, and various catheters and introducer sets including 5F, 10F, and 18F sizes. The diagram also includes lines for venous return, CO2 connection, spikes for heparinized saline bags, a bubble trap, and the Delcath Isofuse Isolation Aspiration Catheter with size dimensions.*

FDA Label Image

Figure (Hep11 0001 05)

Hepzato Kit packaging label for melphalan hydrochloride injection, powder, lyophilized, for solution. This kit is intended for intra-arterial administration. The label displays the proprietary name Hepzato Kit, with the labeler noted as Delcath Systems, Inc. Product NDC 75833-601 is indicated on the packaging.*

FDA Label Image

Figure (Hep11 0001 06)

Hepzato Kit, melphalan hydrochloride injection, powder, lyophilized, for solution in a kit form. The packaging label shows the proprietary name prominently with the generic name and dosage form indicated. The kit is labeled for intra-arterial use and is manufactured by Delcath Systems, Inc. The NDC number 75833-601 appears on the label.*

FDA Label Image

Figure (Hep11 0001 07)

Hepzato Kit packaging label showing the product name Hepzato Kit with melphalan hydrochloride injection, powder, lyophilized for solution. The label includes the dosage form as a kit intended for intra-arterial use, and the labeler is Delcath Systems, Inc. The NDC number 75833-601 is displayed on the label.*

FDA Label Image

Figure (Hep11 0001 08)

Hepzato Kit by Delcath Systems, Inc. features melphalan hydrochloride injection as a powder in a lyophilized form for solution. The image shows a multi-compartment packaging kit designed for intra-arterial administration with detailed compartmental sections and labeling in Japanese, likely indicating container volumes or instructions.*

FDA Label Image

Figure (Hep11 0001 09)

Hepzato Kit packaging label displaying the proprietary name Hepzato Kit. It is a kit containing melphalan hydrochloride injection powder, lyophilized, for solution, intended for intra-arterial use. Labeled by Delcath Systems, Inc., the image includes a red square with the letters PH visible on the panel.*

FDA Label Image

Figure (Hep11 0001 10)

Hepzato Kit packaging label for melphalan hydrochloride injection, powder, lyophilized, for solution. The label displays the proprietary name Hepzato Kit prominently and indicates the product is a kit for intra-arterial use. It includes the lot number, expiration date, and labeler Delcath Systems, Inc. The label also shows barcodes and handling instructions.*

FDA Label Image

Figure (Hep11 0001 11)

Hepzato Kit packaging label showing a small blue square with the letters 'IN' in white, indicating intra-arterial route administration. The label is minimal and part of the product packaging for the melphalan hydrochloride injection, powder, lyophilized, for solution by Delcath Systems, Inc.*

FDA Label Image

Figure (Hep11 0001 12)

An illustration showing two cylindrical filter components mounted on a vertical support, likely part of a medical device or system used for intra-arterial delivery of Hepzato Kit, melphalan hydrochloride injection, lyophilized powder for solution by Delcath Systems, Inc.*

FDA Label Image

Figure (Hep11 0001 13)

The image shows the Hepzato Kit, a human prescription drug by Delcath Systems, Inc., for intra-arterial use. The kit contains two connected cartridge-like containers with gold-colored caps and transparent bodies, likely components of the melphalan hydrochloride injection, powder, lyophilized for solution dosage form.*

FDA Label Image

Figure (Hep11 0001 14)

A medical diagram illustrating a fluid flow system likely related to the Hepzato Kit, showing connectors to heparinized saline bags, a pump head, flow probe, filter inflow and bypass lines, and various labeled tubing segments. The diagram depicts fluid pathways and component interconnections for intra-arterial administration.*

FDA Label Image

Figure (Hep11 0001 15)

An instructional diagram illustrating the filter inflow process for a medical device related to Hepzato Kit. It shows connectors labeled 5 and 6 with arrows indicating the direction of filter inflow, highlighting the flow path through various tubing components.*

FDA Label Image

Figure (Hep11 0001 16)

An instructional illustration depicting a medical filter setup with labeled components and flow directions. It shows two filter outflow sections labeled '7' and '8' merging into a single outflow line indicated at the bottom center of the diagram. The diagram highlights the flow path through the filters and connectors.*

FDA Label Image

Figure (Hep11 0001 17)

Illustration showing components of the Hepzato Kit related to the filter outflow, including tubing connectors labeled E, 7, and 8, with a focus on fluid flow through the filter outflow sections. The right side depicts a detailed filter assembly with an outflow labeled, demonstrating the intra-arterial injection system setup.*

FDA Label Image

Figure (Hep11 0001 18)

An instructional diagram showing a medical tubing set with labeled parts for filter inflow, filter outflow, and filter bypass. The illustration details flow paths and connectors, including a bypass line, focusing on the tube system setup likely associated with the Hepzato Kit intra-arterial use.*

FDA Label Image

Figure (Hep11 0001 19)

Illustration showing a segment of an intra-arterial drug delivery kit with labeled connectors, including a female quick connect, male quick connect, filter outflow points, and an open end. The diagram highlights specific parts for assembly or connection within the Hepzato Kit.*

FDA Label Image

Figure (Hep11 0001 20)

Illustration diagram of the Hepzato Kit showing the flow path through hemofiltration cartridges. The diagram labels filter inflow and outflow lines, bypass line, and key components such as flow probe and various clamps, illustrating the setup for intra-arterial administration with filter bypass option.*

FDA Label Image

Figure (Hep11 0001 21)

An instructional diagram illustrating the Hepzato Kit setup for melphalan hydrochloride injection administration. It details the flow path through filters, including filter inflow and outflow, connections for CO2 source and pressure relief valve, bypass line, flow probe, and luer lock fittings, highlighting sterile filtered CO2 delivery and flow control components used in the kit's intra-arterial route.*

FDA Label Image

Figure (Hep11 0001 22)

Illustration showing a medical setup with two bags labeled Heparinized Normal Saline connected via spikes. Tubing from the bags converges at a Y-connector labeled 'A' and continues down to a valve labeled 'B'. The diagram depicts the flow path for heparinized saline solution administration.*

FDA Label Image

Figure (Hep11 0001 23)

An instructional diagram illustrating components of a Hepzato Kit, including IV spike bags, a pump head with a labeled locking clamp, and sterile wrap. Arrows indicate fluid flow direction and how to close the line by closing the locking clamp, providing a procedural overview of kit assembly or use.*

FDA Label Image

Figure (Hep11 0001 24)

An instructional diagram showing parts of an intravenous flow system, including IV spike bags, a flow probe, filter inflow and bypass lines, and numbered connectors labeled 4, 5, 6, and 10. Blue arrows indicate the direction of flow through components such as filter inflow and bypass paths.*

FDA Label Image

Figure (Hep11 0001 25)

An instructional diagram showing the flow path and components of a filtration system used in a medical setting. It includes labeled elements such as hemofiltration cartridges, filter inflow and outflow, bypass line, flow probe, and IV spike bags, connected by a series of tubing and valves to illustrate fluid direction and control points.*

FDA Label Image

Figure (Hep11 0001 26)

An instructional diagram showing components of a venous return line assembly. It includes a sterile pouch, a venous return line connected to a venous return label, a sterile wrap surrounding part of the line, and a clamp labeled '9'. The diagram highlights the connection and packaging of the venous return line components.*

FDA Label Image

Figure (Hep11 0001 27)

An instructional medical diagram illustrating a fluid administration system for the Hepzato Kit. It shows labeled components such as Female and Male Quick Connects, a Bubble Trap, Venous Return line, Filter Outflow connectors, and a Sterile Wrap. The illustration details fluid flow direction and connection points.*

FDA Label Image

Figure (Hep11 0001 28)

An instructional diagram illustrating the setup and flow direction of a hemofiltration system, including labeled components such as hemofiltration cartridges, filter inflow and outflow, filter bypass, venous return, bypass line, and various stopcocks and connectors. Arrows indicate flow paths and locations for sterile wrap and aspiration instructions.*

FDA Label Image

Figure (Hep11 0001 29)

Diagram showing components of a Hepzato Kit intra-arterial setup, including a pressure monitoring line, a flow probe, and tubing connections marked for assembly or monitoring.*

FDA Label Image

Figure (Hep11 0001 30)

An illustration diagram depicting medical lines and valves for Hepzato Kit, including labeled components: filter inflow, bypass line, filter bypass, and pressure monitoring line. The diagram shows the flow path and connection points, marked with numbers and letters for reference, used in the intra-arterial melphalan hydrochloride injection kit by Delcath Systems, Inc.*

FDA Label Image

Figure (Hep11 0001 31)

An anatomical illustration showing the positioning of a 10F venous return sheath inserted into the internal jugular vein for intra-arterial administration. The diagram highlights vascular access and catheter placement relevant to the Hepzato Kit procedure.*

FDA Label Image

Figure (Hep11 0001 32)

An anatomical diagram showing the femoral artery with a 5F introducer device inserted, labeled as for hepatic arterial infusion catheter placement. The illustration depicts catheter insertion through the femoral artery for intra-arterial administration.*

FDA Label Image

Figure (Hep11 0001 33)

An anatomical illustration showing the placement of an 18F venous sheath in the femoral vein. The diagram details the venous access route leading towards the heart and liver, highlighting relevant blood vessels for intra-arterial administration.*

FDA Label Image

Figure (Hep11 0001 34)

An anatomical line drawing showing the placement of a 5F infusion catheter and an introducer sheath in the vascular system. The diagram highlights the hepatic blood vessels and their relation to the heart, illustrating catheter insertion for intra-arterial delivery.*

FDA Label Image

Figure (Hep11 0001 35)

An instructional diagram illustrating the components and connections of the Hepzato Kit, showing fluid bags, tubing with labeled junction points, and a double balloon catheter. The diagram highlights the flow direction within the intra-arterial delivery system for melphalan hydrochloride injection.*

FDA Label Image

Figure (Hep11 0001 36)

Diagram of the Hepzato Kit assembled system showing the flow pathway for intra-arterial administration. It features components including double balloon catheter lines, hemofiltration cartridges, pressure monitoring lines, bubble trap, and venous return line, with labeled connection points and directional flow arrows for the setup.*

FDA Label Image

Figure (Hep11 0001 37)

An angiographic image showing a balloon indentation in a vessel, annotated as 'Balloon indentation – Acorn Shape.' The image appears to illustrate a procedural or anatomical detail relevant to the intra-arterial administration route, possibly linked to the use of the Hepzato Kit product.*

FDA Label Image

Figure (Hep11 0001 38)

An angiographic image showing intra-arterial contrast flow through blood vessels, highlighting the branching vascular structure typically seen in liver or abdominal artery imaging. This image relates to intra-arterial administration of melphalan hydrochloride injection in Hepzato Kit.*

FDA Label Image

Figure (Hep11 0001 39)

Illustration of the Hepzato Kit assembled system showing the flow path for intra-arterial administration, including double balloon catheter, hemofiltration cartridges, pressure monitoring lines, bubble trap, and venous return line with labeled connection points and catheters.*

FDA Label Image

Figure (Hep11 0001 40)

An instructional illustration showing the setup for administering Hepzato Kit drug solution. It includes two IV bags labeled as 'HEPZATO drug solution bag provided by pharmacy' and 'Normal Saline bag for priming and flushing the system,' connected by 48-inch injection lines with valves leading to an injection apparatus. The diagram highlights the flow path for intra-arterial administration.*

FDA Label Image

Figure (Hep11 0001 41)

An instructional diagram showing three syringes labeled CONTRAST, NTG, and NORMAL SALINE connected to a multi-valve manifold used for flushing between contrast injections, performing vessel spasm checks, and administering intra-arterial NTG. A text box provides recommendations to use two stopcocks, keep the NTG syringe on the back table, and replace the saline syringe when NTG is required to reduce inadvertent NTG administration.*

FDA Label Image

Figure (Hep11 0001 42)

An instructional diagram showing components of the Hepzato Kit including syringes labeled for normal saline, contrast, and IANTG injections, a Hepzato drug solution bag, a normal saline bag for priming and flushing, and a 48-inch injection line connecting these elements, illustrating the setup for intra-arterial administration.*

FDA Label Image

Figure (Hep11 0001 43)

Illustrative diagram of the Hepzato Kit intra-arterial system showing the assembled components including the double balloon catheter, hemofiltration cartridges, pressure monitoring lines, flow probe, venous return line, and associated tubing. The diagram also highlights the catheter positioning within the vascular system near the heart with labeled infusion and venous return sheaths.*

FDA Label Image

Figure (Hep11 0001 44)

Flowchart illustrating the step-by-step procedure for administering the Hepzato Kit involving multiple roles: anesthesiologist, radiologist (IR), oncologist, perfusionist, registered nurse, and intensive care unit staff. It details sequential activities including patient preparation, catheter placement, drug preparation and delivery, monitoring perfusion parameters, filtration, washout, and post-procedure patient evaluation and discharge. Color-coded sections indicate responsibilities and timing within an interventional radiology suite and ICU.*

FDA Label Image

Figure (Hep11 0001 45)

FDA Label Image

Figure (Hep11 0001 46)

Hepzato Kit packaging shows a white box with blue accents. The label includes the proprietary name Hepzato Kit and identifies the product as melphalan hydrochloride injection, powder, lyophilized, for solution. It is an intra-arterial kit labeled by Delcath Systems, Inc. The box design is simple with product information centered and clean.*

FDA Label Image

Principal Display Panel (Kit Label)

Label for Hepzato Kit (melphalan) for Injection/Hepatic Delivery System by Delcath Systems, Inc. The label identifies REF 601002 with placeholders for expiration date and lot number. It lists contents including a 62 mm Double Balloon Catheter and vials of melphalan powder and diluent. Packaging instructions, storage temperature, warnings, and barcode are also displayed.*

FDA Label Image

Principal Display Panel – 50 mg Vial Label (Hep11 0001 48)

Label of Hepzato Kit single-dose vial containing 50 mg of melphalan hydrochloride for injection, a hazardous drug for intra-arterial infusion. Manufactured for Delcath Systems, Inc. by Mylan Institutional LLC in Italy. The label includes storage instructions and a warning about reconstitution and delivery system use.*

FDA Label Image

Principal Display Panel – 10 mL Diluent Vial Label (Hep11 0001 49)

Label for Hepzato Kit diluent vial, sterile and single-dose. Contains components including sodium citrate, propylene glycol, ethanol, and water for injection. Manufactured for Delcath Systems, Inc., Queensbury, NY by Mylan Institutional LLC, made in Italy. Storage at controlled room temperature (20°C to 25°C) advised.*

FDA Label Image

Principal Display Panel (0.9 g/250 mL Container Label)

Label for 0.9% Sodium Chloride Injection USP in a 250 mL container by B. Braun Medical Inc. The label includes NDC 0264-7800-20, REF L8002, and details about sterility, storage, and usage instructions. The product is a sterile, nonpyrogenic sodium chloride injection solution with pH 5.6 and specific electrolyte concentrations. The label includes warnings and handling instructions along with barcode placeholders and distributor information for the U.S. and Canada.*

* 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.