Artiss Solution
NDC Package 0338-9641-01
Package Information
Artiss (fibrinogen human, human thrombin) solution is 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. This formulation utilizes a solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9641 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
- 0338-9641 - Artiss
- 0338-9641-01 - 10 mL in 1 SYRINGE, PLASTIC
- 0338-9641 - 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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 0338-9641-01 identifies a specific commercial package of 10 ml in 1 syringe, plastic of Artiss Fibrin Sealant, a plasma derivative labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This solution is formulated for topical use and contains fibrinogen human; human thrombin as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Baxter Healthcare Corporation on March 19, 2008. The current certification is valid through December 31, 2027.
How is this Baxter Healthcare Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338964101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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.
