Artiss
NDC Package 0338-8503-04
Package Information
Artiss is a fibrin sealant indicated to:•Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.•Adhere tissue flaps during facial rhytidectomy surgery (face-lift).ARTISS is not indicated as an adjunct to hemostasis. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-8503 and is authorized under FDA application BLA125266.
Identification & Billing
- RxCUI: 1305891 - fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen
- RxCUI: 1305891 - 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe
- RxCUI: 1305891 - fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen
- RxCUI: 1305892 - ARTISS (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe
- RxCUI: 1305892 - 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0338 - Baxter Healthcare Corporation
- 0338-8503 - Artiss
- 0338-8503-04 - 1 SYRINGE, PLASTIC in 1 CARTON / 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03)
- 0338-8503 - Artiss
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0338-8503). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0338-8503-04 identifies a specific commercial package of 1 syringe, plastic in 1 carton / 4 ml in 1 syringe, plastic (0338-8503-03) of Artiss Fibrin Sealant, labeled by Baxter Healthcare Corporation. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Baxter Healthcare Corporation on March 19, 2008. The current certification is valid through April 30, 2024.
How is this Baxter Healthcare Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338850304. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
