Artiss
Product Images NDC 0338-8503

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

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Artiss (NDC 0338-8503). 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: Duo Set A (Image 01)

Figure 1:  Duo Set A (Image 01)
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 2ml Pouch Label Ndc 0338-8503-01 (Image 02)

Representative 2ml Pouch Label  Ndc 0338-8503-01 (Image 02)
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 2ml Carton Label (1 of 2 NDC 0338-8503-02)

Representative 2ml Carton Label (1 of 2   NDC 0338-8503-02)
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 2ml Carton Label (2 of 2 NDC 0338-8503-02)

Representative 2ml Carton Label (2 of 2   NDC 0338-8503-02)
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 Duo Set A 2 mL 4 mL Label (Image 05)

Representative Duo Set A 2 mL 4 mL Label (Image 05)
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

Image 06

Image 06
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

Image 07

Image 07
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

Image 08

Image 08
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

Image 09

Image 09
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

Image 10

Image 10
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

Image 11

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.*
FDA Label Image

Image 12

Image 12
The packaging label for Artiss 4 mL Fibrin Sealant (Human) by Baxter Healthcare Corporation. The label highlights the product as vapor heated, solvent/detergent treated, and frozen. It includes details about the pre-filled syringe contents, storage instructions, and usage warnings. The label also shows a clear image of the pre-filled syringe with measurement markings.*
FDA Label Image

Image 13

Image 13
ARTISS Fibrin Sealant 10 mL pre-filled syringe label from Baxter Healthcare Corporation. The label indicates it contains sealer protein solution and thrombin solution, with human fibrinogen at 86.5 mg/mL and aprotinin, synthetic at 3000 KIU/mL. It is labeled for topical use only, frozen storage, and warns not to expose above 37°C. Includes manufacturer and storage instructions.*
FDA Label Image

Image 14

Image 14
Packaging label for Artiss 10 mL Fibrin Sealant (Human) by Baxter Healthcare Corporation. The label indicates the product is vapor heated and solvent/detergent treated, frozen. The primary strength described is 10 mL volume. The label includes the Baxter logo and display of the syringe applicator.*
FDA Label Image

Image 15

Image 15
Packaging label for Artiss 10 mL Fibrin Sealant (Human) by Baxter Healthcare Corporation. The label indicates the product is vapor heated, solvent/detergent treated, and frozen. It includes contents for a pre-filled syringe with fibrinogen, fibrinolysis inhibitor, thrombin solution, and calcium chloride, along with warnings for topical use only, storage instructions, and patient use limitations. The label also features a barcode and an image of the syringe applicator.*
FDA Label Image

Image 16

Image 16
The image shows a packaging label for Baxter's DUPLOJECT COMBI, a device for applying TISSEEL and ARTISS Fibrin Sealant. It includes an illustration of the Duploject applicator with numbered parts. The label highlights batch code and use-by date fields and lists manufacturer details: Baxter Healthcare Corporation, Deerfield, IL, USA, with production in Belgium.*

* 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.