Artiss Solution
Product Images NDC 0338-9641

11 FDA label images from Baxter Healthcare Corporation · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Artiss (NDC 0338-9641). 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 (PRIMA Syringe)

Figure 1: Duploject Combi (PRIMA Syringe)
Illustration diagram of ARTISS Fibrin Sealant application components, showing a labeled double chamber syringe with a double plunger, joining piece, tether strap, and application cannula.*
FDA Label Image

Representative Pouch Label (2mL 0338-9637-01)

Representative Pouch Label (2mL 0338-9637-01)
An instructional diagram of the ARTISS Fibrin Sealant delivery system components, including the double chamber syringe with double plunger, a joining piece, a tether strap, and an application cannula, showing how these parts connect for application.*
FDA Label Image

Representative Carton Label (2mL 0338-9637-01 1 of 2)

Representative Carton Label (2mL 0338-9637-01 1 of 2)
ARTISS Fibrin Sealant 2 mL pre-filled syringe label by Baxter Healthcare Corporation. The label details it contains two sterile solutions: Sealer Protein Solution with 86.5 mg/mL human fibrinogen and 3000 KIU/mL synthetic aprotinin, and Thrombin Solution with 4 units/mL human thrombin and 40 µmol/mL calcium chloride. The product is frozen, temperature sensitive, for topical use only (not for injection), and must be thawed before use. Storage instructions and regulatory information are also included.*
FDA Label Image

Representative Carton Label (2mL 0338-9637-01 2 of 2)

Representative Carton Label (2mL 0338-9637-01 2 of 2)
ARTISS Fibrin Sealant (Human) 2 mL pre-filled syringe packaging label by Baxter Healthcare Corporation. The label indicates the product contains vapor heated, solvent/detergent treated, frozen fibrin sealant for topical use only, with strengths including 86.5 and 4 mg/mL. The label also includes usage instructions and barcode.*
FDA Label Image

Representative Pouch Label (4mL 0338-9639-01)

Representative Pouch Label (4mL 0338-9639-01)
Packaging label for ARTISS Fibrin Sealant (Human) by Baxter Healthcare Corporation. The label specifies a 2 mL pre-filled syringe, vapor heated, solvent/detergent treated, and frozen. Includes warnings for topical use only and not for injection. The product is manufactured in Austria with Baxter branding prominently displayed.*
FDA Label Image

Representative Carton Label (4mL 0338-9639-01 1 of 2)

Representative Carton Label (4mL 0338-9639-01 1 of 2)
Instructional diagram for ARTISS Fibrin Sealant Duo Set A 2 ml / 4 ml by Baxter Healthcare Corporation. The image shows a three-step assembly for application: opening the sealed tubes, attaching components to a dual-syringe applicator device, and connecting the applicator tip for use. Additional text includes usage instructions, sterilization method, and manufacturing information.*
FDA Label Image

Representative Carton Label (4mL 0338-9639-01 2 of 2)

Representative Carton Label (4mL 0338-9639-01 2 of 2)
ARTISS Fibrin Sealant 2 mL vial label by Baxter Healthcare Corporation. The label details a frozen, temperature-sensitive fibrin sealant for topical use containing sealer protein solution with 86.5 mg/mL fibrinogen and 3000 IU/mL fibrinolysis inhibitor, plus thrombin solution with 4 units/mL thrombin and calcium chloride. It includes storage instructions and warnings not to inject.*
FDA Label Image

Representative Pouch Label (10mL 0338-96341-01)

Representative Pouch Label (10mL 0338-96341-01)
Packaging label for ARTISS Fibrin Sealant 2 mL by Baxter Healthcare Corporation. The label highlights the product as a human fibrin sealant that is vapor heated, solvent/detergent treated, and frozen. The label includes the Baxter logo and a syringe illustration indicating the 2 mL volume.*
FDA Label Image

Representative Carton Label (10mL 0338-9641-01 1 of 2)

Representative Carton Label (10mL 0338-9641-01 1 of 2)
Carton packaging label for Artiss 2 mL Fibrin Sealant [Human] by Baxter Healthcare Corporation. The label indicates the product is vapor heated, solvent/detergent treated, and frozen. It includes details about the contents in pre-filled syringes, usage instructions for topical use only, storage conditions, and warnings. The label shows the Baxter logo, a 2 mL volume indicator, and an image of a dual-syringe applicator device.*
FDA Label Image

Representative Carton Label (10mL 0338-9641-01 2 of 2)

Representative Carton Label (10mL 0338-9641-01 2 of 2)
Label for ARTISS Fibrin Sealant 4 mL by Baxter Healthcare Corporation. It contains Fibrin Sealant (Human) with 86.5 mg/mL Fibrinogen and Aprotinin 3000 KIU/mL in the Sealer Protein Solution, and 4 units/mL Thrombin and 40 µmol/mL Calcium Chloride in the Thrombin Solution. The label states temperature sensitivity and storage instructions.*
FDA Label Image

Duploject Combi Representative Label (Image 11)

Duploject Combi Representative Label (Image 11)
Packaging label for Artiss 4 mL fibrin sealant [Human] by Baxter Healthcare Corporation. The label states the product is vapor heated, solvent/detergent treated, and frozen. The label prominently displays '4 mL' in red circles and includes an image of the product syringe.*

* 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.