Figure 1: Duo Set A (Image 01)
Artiss Solution
Product Images NDC 0338-9639
View Photos of 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 0338-9639). 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.
Product Images & Figures Index
Representative 2ml Pouch Label Ndc 0338-8503-01 (Image 02)
This text is describing different medical equipment like a Tether Strap, Z Double Plunger, Joining Piece and an Application Cannula. It is not providing any further information or context about the products, their purposes or how to use them.*
Representative 2ml Carton Label (1 of 2 NDC 0338-8503-02)
This is a description of a medical product called "Fibrin Sealant (Human)" manufactured by Baxter. It is a pre-filled syringe for topical use only and should not be injected. It contains Sealer Protein Solution, Fibrinogen, Fibrinolysis Inhbitor (Aprotiin, Synthetic), Thrombin Solution, and Galcium Chioride. The product should not be exposed above 37°C (99°F) and must be thawed before use. The thawed product can be stored for up to 14 days at 15-25°C. The Lot No. and Expiration Date are also displayed.*
Representative 2ml Carton Label (2 of 2 NDC 0338-8503-02)
Representative Duo Set A 2 mL 4 mL Label (Image 05)
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This is a product description of the Baxter DUO Set used for the application of ARTISS Fibrin Sealant, manufactured by Baxter Healthcare Corporation in Deerfield, Illinois, USA. It is sterilized by gamma radiation and is for single use without containing natural rubber latex. It comes in a set of 2 ml and 4 ml.*
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This text describes the ARTISS product, which is a pre-filled syringe containing a fibrin sealant solution used for surgical procedures. The solution should be stored at a temperature below 3°C and should not be frozen. The package contains fibrinogen (human), thrombin (human), and other synthetic components. The syringe should not be injected directly into the body, and instructions should be read before use. The product should be stored in a cool environment and has a limited shelf life of up to 14 days. It was manufactured by Baxter Healthcare Corporation.*
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This is a description of a pre-filled syringe of sealant for human use. The syringe includes a sealer protein solution, fibrinogen, and thrombin solution, along with calcium chloride. The contents are temperature-sensitive and should not be exposed to a temperature above 37°C. The sealant is intended for topical use only, and injection is prohibited. The package should be stored at -20°C or colder. The contents have been sterilized and packaged under aseptic conditions by Baxter Healthcare Corporation. Lot number and expiry date are provided, in addition to the NDC code.*
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This is a description of Fibrin Sealant (Human) - a pre-filled syringe with 10 mL e capacity that is to be used topically. It is comprised of Sealer Protein Solution, Fibrinogen (Human), Fibrinolysis Inhibitor (Aprotinin, Synthetic), and Thrombin Solution. The sealant is temperature sensitive and must not be exposed above 37°C (99°F). It is recommended to store unopened pouches at -20°C (~4°F) or below. The solution contains 86.5 mg/mL Fibrinogen (Human), 3000 KIU/mL Fibrinolysis Inhibitor (Aprotinin, Synthetic), and 4 units/mL Thrombin (Human). The solution also contains Calcium Chloride at a concentration of 40 ymol/mL. It is packaged under aseptic conditions and must not be refrigerated, microwaved, or freeze-dried. The product is manufactured in Deerfield, IL, USA under license number 140. Lot number and date information is provided as well.*
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The text describes the Duploject Combi by Baxter, which is intended for administering the Tisseel and Artiss Fibrin Sealant. The product is sterile and should only be used for its intended purpose. It is not made with natural latex and should not be resterilized. The product is packaged in a sealed and undamaged package, and has a Balch code and use-by date. The company's information including name, address and contact number as well as where the product is made is also provided.*
* 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.
