Tisseel Kit
Product Images NDC 0338-4212

Product Visual Gallery

This gallery contains 33 technical images submitted to the FDA as part of the official labeling for Tisseel (NDC 0338-4212). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Baxter Healthcare Corporation, 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 1 Duploject Combi (Image 01)

An instructional diagram showing the components of the TISSEEL Fibrin Sealant delivery system. It includes a labeled double plunger, double chamber syringe connected via a joining piece with a tether strap, and an application cannula at the tip for precise product administration.*

FDA Label Image

Tisseel Lyo 2ml Representative Carton Label 1 Of 2 Ndc 0338-4210-02 (Image 02)

An instructional illustration of a double chamber syringe assembly for TISSEEL Fibrin Sealant. The diagram labels parts including the double plunger, double chamber syringe, joining piece, tether strap, and the application cannula, showing the components used for product application.*

FDA Label Image

Tisseel Lyo 2ml Representative Carton Label 2 Of 2 Ndc 0338-4210-02 (Image 03)

Packaging label for TISSEEL Fibrin Sealant 2 mL by Baxter Healthcare Corporation. The label indicates the product is vapor heated, solvent/detergent treated, and frozen. It is temperature sensitive, with storage instructions at -20°C or colder, and warnings not to refrigerate or re-freeze. The pre-filled syringe contains Sealer Protein Solution and Thrombin Solution with specified contents and strengths, intended for topical use only.*

FDA Label Image

Tisseel Lyo 2ml Representative Sleeve Label 1 Of 4 Ndc 0338-4301-02 (Image 04)

Packaging label for TISSEEL Fibrin Sealant by Baxter Healthcare Corporation. The label indicates a 2 mL package size and mentions the product is vapor heated, solvent/detergent treated, and frozen. The label includes images of the product's pre-filled syringe and states 'Topical Use Only.'*

FDA Label Image

Tisseel Lyo 2ml Representative Sleeve Label 2 Of 4 Ndc 0338-4301-02 (Image 05)

Packaging label for TISSEEL Fibrin Sealant pre-filled syringe with a 2 mL volume. The label highlights that the product is vapor heated, solvent/detergent treated, and frozen. It is manufactured by Baxter Healthcare Corporation. The label includes a syringe icon and emphasizes topical use only, not for injection.*

FDA Label Image

Tisseel Lyo 2ml Representative Sleeve Label 3 Of 4 Ndc 0338-4301-02 (Image 06)

Label for TISSEEL Fibrin Sealant 2 mL kit by Baxter Healthcare Corporation. The label states it is vapor heated, solvent/detergent treated, containing Sealer Protein Concentrate 86.5 mg/mL, Fibrinolysis Inhibitor Solution (3000 KIU/mL), Thrombin 500 units/mL, and Calcium Chloride 40 µmol/mL. The label notes single-use only, not for injection, and no natural rubber latex.*

FDA Label Image

Tisseel Lyo 2ml Representative Sleeve Label 4 Of 4 Ndc 0338-4301-02 (Image 07)

Packaging label for TISSEEL Fibrin Sealant 2 mL, a vapor heated, solvent/detergent treated kit. The label shows a blue background section with manufacturer information for Baxter Healthcare Corporation and a white section with a green circle highlighting the 2 mL volume. Storage instructions recommend keeping at 2°C to 25°C and avoiding freezing.*

FDA Label Image

Tisseel Lyo 2 mL (4 mL DUPLOJET Repesentative Label 1 of 4)

Packaging label for TISSEEL Fibrin Sealant 2 mL, a vapor heated and solvent/detergent treated kit. The label shows the Baxter logo and states the labeler as Baxter Healthcare Corporation, with manufacturing details including made in Austria and U.S. license number 140.*

FDA Label Image

Tisseel Lyo 2 mL (4 mL DUPLOJET Repesentative Label 2 of 4)

Packaging label for TISSEEL Fibrin Sealant 2 mL, a vapor heated, solvent/degrepent treated kit by Baxter Healthcare Corporation. The label features an image of a dual-chamber syringe with red plungers and a needle, set against a blue background. The label includes usage instructions indicating 'Topical use only, do not inject.'*

FDA Label Image

Tisseel Lyo 2 mL (4 mL DUPLOJET Repesentative Label 3 of 4)

TISSEEL Fibrin Sealant 2 mL Kit packaging label by Baxter Healthcare Corporation. The label indicates a vapor heated, solvent/detergent treated fibrin sealant containing sealed protein concentrate (86.5 mg/mL), fibrinolysis inhibitor solution (3000 KIU of Aprotinin/mL), thrombin solution (500 units/mL), and calcium chloride solution (40 µmol/mL). Includes DUPLOJECT Fibrin Sealant Preparation and Application System 2 mL / 4 mL. For single use only and not for injection.*

FDA Label Image

Tisseel Lyo 2 mL (4 mL DUPLOJET Repesentative Label 4 of 4)

Barcode label for TISSEEL Fibrin Sealant by Baxter Healthcare Corporation. The label shows a barcode with the number 0338-4301-02. No additional product details or package information are visible on this label.*

FDA Label Image

Duplojet Ifu Representative Label 1 Of 4 (Image 12)

Instructional diagram showing the DUO Set 2 ml / 4 ml applicator for TISSEEL Fibrin Sealant from Baxter Healthcare Corporation. The three-step illustration displays assembly and use of the applicator components. The label notes single use, no natural rubber latex, sterilization by gamma radiation, and that it is sterile and non-pyrogenic in unopened, undamaged packaging, manufactured in Belgium.*

FDA Label Image

Duplojet Ifu Representative Label 2 Of 4 (Image 13)

Packaging label for TISSEEL Fibrin Sealant, DUPLOJECT 2 mL / 4 mL Fibrin Sealant Preparation and Application System by Baxter Healthcare Corporation. The label features the Baxter logo, product name, volume specifications, and manufacturer information including address and contact number. The design includes a blue background with a small airplane graphic.*

FDA Label Image

Duplojet Ifu Representative Label 3 Of 4 (Image 14)

Packaging label for DUPLOJECT Fibrin Sealant Preparation and Application System, indicating availability in 2 mL or 4 mL kit sizes for use with fibrin sealant. The label includes a color-coded circle highlighting the two volume options (2 mL in green and 4 mL in red). Baxter Healthcare Corporation is the labeler.*

FDA Label Image

Duplojet Ifu Representative Label 4 Of 4 (Image 15)

Text panel titled 'Indications for Use' for TISSEEL Fibrin Sealant 2 mL / 4 mL Kit. It instructs on preparation and application, states the product is sterile and for single patient use only without resterilization, notes use of separate devices for reconstitution of Sealer Protein Concentrate and Thrombin, and indicates Rx only. The product is made in Belgium by Baxter Healthcare Corporation.*

FDA Label Image

Representative Pouch Label Ndc 0338-9560-01 (Image 16)

Packaging label for DUPLOJECT Fibrin Sealant Preparation and Application System kit, offering 2 mL or 4 mL options. The label highlights the kit is used for fibrin sealant preparation and application, with the volumes prominently displayed in green and red circles. Labeler is Baxter Healthcare Corporation.*

FDA Label Image

Representative Carton Label Ndc 0338-9560-01 1 Of 2 (Image 17)

This text panel provides detailed reconstitution instructions for the DUPLOJECT Fibrin Sealant Preparation and Application System. It covers steps for warming, assembling, withdrawing solutions, and activating the FIBRINOTHERM device to prepare TISSEEL Fibrin Sealant kit for clinical use. The labeler Baxter Healthcare Corporation is mentioned in the product data.*

FDA Label Image

Representative Carton Label Ndc 0338-9560-01 2 Of 2 (Image 18)

A text panel titled 'Preparation Instructions for the Scrub Nurse' providing step-by-step instructions for preparing the DUPLOJECT Preparation and Application System, including opening packs, assembling syringes, withdrawing Sealer Protein Solution and Thrombin Solution from vials, and ensuring syringes contain equal volumes.*

FDA Label Image

Representative Pouch Label Ndc 0338-9564-01 (Image 19)

Instructional diagram for assembling the TISSEEL Fibrin Sealant DUPLOJECT applicator system, showing two syringes being snapped into a two-syringe clip, attachment of a joining piece to the syringe nozzles, and fitting of an application cannula. The image highlights proper assembly steps before use.*

FDA Label Image

Representative Carton Label Ndc 0338-9564-01 1 Of 2 (Image 20)

A text panel for TISSEEL Fibrin Sealant including usage warnings such as 'Rx Only,' instructions not to reuse or resterilize, and information that the product is not made with natural rubber latex. It states the product is sterile and non-pyrogenic when unopened and undamaged and advises proper disposal of contaminated and sharp components. Manufactured for Baxter Healthcare Corporation in Deerfield, IL, USA, with a manufacturing origin in Belgium and a revision date of May 17, 2017.*

FDA Label Image

Representative Carton Label Ndc 0338-9564-01 2 Of 2 (Image 21)

Label for TISSEEL Fibrin Sealant 2 mL by Baxter Healthcare Corporation. The label indicates the product is vapor heated, solvent/detergent treated, and frozen. It includes warnings about temperature sensitivity and not injecting the product, specifies topical use only, and lists storage instructions. The contents are described as pre-filled syringes containing Sealer Protein Solution and Thrombin Solution with specific concentrations of fibrinogen, fibrinolysin inhibitor, thrombin, and calcium chloride. Manufacturer details and lot number barcode are also shown.*

FDA Label Image

Representative Pouch Label Ndc 0338-9568-01 (Image 22)

Packaging label for TISSEEL Fibrin Sealant, a 2 mL vial by Baxter Healthcare Corporation. The label states the product as a white-pre-filled PRMA syringe containing vapor heated, solvent/detergent treated, frozen fibrin sealant. It includes usage instructions noting top gal use only and storage guidelines. The box displays the labeler name and a barcode.*

FDA Label Image

Representative Carton Label Ndc 0338-9568-01 1 Of 2 (Image 23)

The packaging label for TISSEEL Fibrin Sealant by Baxter Healthcare Corporation features a black and blue design with white text. It indicates the product is vapor heated, solvent/detergent treated, and frozen, intended for topical use only and not for injection. The label highlights a pre-filled PRIMA syringe containing 2 mL of fibrin sealant. Manufacturer information, patent details, and trademark acknowledgments are also included.*

FDA Label Image

Representative Carton Label Ndc 0338-9568-01 2 Of 2 (Image 24)

Label for TISSEEL Fibrin Sealant 4 mL by Baxter Healthcare Corporation. The product is a temperature-sensitive, frozen fibrin sealant with 86.5 mg/mL fibrinogen and 500 units/mL thrombin. It includes sealed protein and thrombin solutions for topical use only, with storage instructions and warnings against injection and exposure above 37°C (99°F). Manufactured by Baxter Healthcare Corporation in Deerfield, IL.*

FDA Label Image

Tisseel Lyo 4ml Vial Carton Label 0338-4211-04 1 Of 2 (Image 25)

Packaging label for TISSEEL Fibrin Sealant, 4 mL vial, manufactured by Baxter Healthcare Corporation. The label features branding elements, volume indication (4 mL), and a syringe image illustrating the product. Additional text pertains to usage directions and warnings.*

FDA Label Image

Tisseel Lyo 4ml Vial Carton Label 0338-4211-04 2 Of 2 (Image 26)

Packaging label for TISSEEL Fibrin Sealant, 4 mL, featuring a pre-filled PRIMA syringe. The label indicates the product is vapor heated, solvent/detergent treated, frozen, and for topical use only, not for injection. Manufactured for Baxter Healthcare Corporation, with a reorder number and a patent reference. The packaging has a black background with blue and orange accents.*

FDA Label Image

Tisseel Lyo 10ml Vial Carton Label 0338-4212-10 1 Of 2 (Image 27)

Label for TISSEEL Fibrin Sealant 10 mL by Baxter Healthcare Corporation. The label indicates vapor heated, solvent/detergent treated, frozen product with storage instructions and warnings not to expose above 37°C. It includes contents details listing pre-filled syringes containing sealer protein solution with fibrinogen and fibrinolysis inhibitor, and thrombin solution with thrombin and calcium chloride. Manufactured in Deerfield, Illinois, USA.*

FDA Label Image

Tisseel Lyo 10ml Vial Carton Label 0338-4212-10 2 Of 2 (Image 28)

This is the packaging label for TISSEEL Fibrin Sealant, a 10 mL vial of vapor heated, solvent/detergent treated, frozen fibrin sealant with pre-filled priming syringe. The label is primarily dark with blue and white accents and features a syringe illustration. Manufactured by Baxter Healthcare Corporation.*

FDA Label Image

Tisseel Lyo 4ml Sleeve Carton Label 0338-4302-04 1 Of 2 (Image 29)

TISSEEL Fibrin Sealant packaging label showing a 10 mL pre-filled PRIMA syringe with vapor heated, solvent/detergent treated, frozen fibrin sealant for topical use only. The label displays the product name, usage instructions, manufacturer Baxter Healthcare Corporation, and indicates the package volume as 10 mL.*

FDA Label Image

Tisseel Lyo 4ml Sleeve Carton Label 0338-4302-04 2 Of 2 (Image 30)

Packaging label for TISSEEL Fibrin Sealant 4 mL kit by Baxter Healthcare Corporation. The label states it is vapor heated and solvent/detergent treated. It lists contents including Sealer Protein Concentrate 86.5 mg/mL, Fibrinolysis Inhibitor Solution 3000 KIU/mL, Thrombin 500 units/mL, and Calcium Chloride Solution 40 µmol/mL. The label also includes product warnings and usage instructions.*

FDA Label Image

Tiseel Lyo 10ml Sleeve Carton Label 0338-4303-10 1 Of 2 (Image 31)

Packaging label for TISSEEL Fibrin Sealant 4 mL kit by Baxter Healthcare Corporation. The label states the product is vapor heated and solvent/detergent treated. Manufactured in Austria for Baxter Healthcare in Deerfield, IL. Includes storage instructions to store at 2°C to 25°C and avoid freezing.*

FDA Label Image

Tiseel Lyo 10ml Sleeve Carton Label 0338-4303-10 2 Of 2 (Image 32)

Packaging label for TISSEEL Fibrin Sealant 10 mL, vapor heated, solvent/detergent treated kit. Label shows the Baxter logo, active components including Sealer Protein Concentrate (86.5 mg/mL), Fibrinolysis Inhibitor Solution (3000 KIU/mL Aprotinin), Thrombin (500 units/mL), and Calcium Chloride Solution (40 µmol/mL). Includes usage instructions and warnings relevant to the kit.*

FDA Label Image

Tisseel Duploject Combi Label (Image 33)

Packaging label for TISSEEL Fibrin Sealant 10 mL kit by Baxter Healthcare Corporation. The label includes storage instructions (2°C to 25°C) and notes the product is vapor heated, solvent/detergent treated. Manufactured for Baxter Healthcare in Deerfield, IL, USA, and made in Austria. The label also displays a barcode and patent number.*

* 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.