Vistaseal Solution
NDC Package 61953-0020-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Vistaseal (human fibrinogen, human thrombin) solution is vISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. This formulation utilizes a solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 61953-0020 and is authorized under FDA application BLA125640.

Identification & Billing

NDC Package Code
61953-0020-1
Package Description
1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION / 2 mL in 1 SYRINGE, GLASS (61953-0020-2)
Product Code
61953-0020
11-Digit Billing Format
61953002001
RxNorm Crosswalk
  • RxCUI: 2264366 - fibrin sealant (thrombin 500 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen
  • RxCUI: 2264366 - 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
  • RxCUI: 2264366 - fibrin sealant (thrombin 500 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen
  • RxCUI: 2264371 - VistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe
  • RxCUI: 2264371 - 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]

Clinical Specifications

Proprietary Name
Vistaseal
Non-Proprietary Name
Human Fibrinogen, Human Thrombin
Substance Name
Fibrinogen Human; Human Thrombin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA125640
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-01-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 (61953-0020). Click a package code to view its specific billing and regulatory data.

61953-0020-3
1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION / 4 mL in 1 SYRINGE, GLASS (61953-0020-4)
61953-0020-5
1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION / 6 mL in 1 SYRINGE, GLASS (61953-0020-6)
61953-0020-7
1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION / 10 mL in 1 SYRINGE, GLASS (61953-0020-8)

* 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 61953-0020-1 identifies a specific commercial package of 1 syringe, glass in 1 package, combination / 2 ml in 1 syringe, glass (61953-0020-2) of Vistaseal, a plasma derivative labeled by Grifols Usa, Llc. 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 Grifols Usa, Llc on November 01, 2019. The current certification is valid through December 31, 2026.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61953002001. 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:

10-Digit Format (5-4-1)
61953-0020-1
11-Digit CMS (5-4-2)
61953-0020-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.