Vistaseal Kit
NDC Package 61953-0011-1

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

Package Information

Vistaseal (human fibrinogen, human thrombin) kits is vISTASEAL is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. This formulation utilizes a kit delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 61953-0011 and is authorized under FDA application BLA125640.

Identification & Billing

NDC Package Code
61953-0011-1
Package Description
1 KIT in 1 PACKAGE, COMBINATION * 1 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS
Product Code
61953-0011
11-Digit Billing Format
61953001101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Dosage Form
Kit - A packaged collection of related material.
Usage Information
VISTASEAL is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults 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
End Marketing Date
03-11-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61953-0011-1 identifies a specific commercial package of 1 kit in 1 package, combination * 1 ml in 1 syringe, glass * 1 ml in 1 syringe, glass of Vistaseal, a plasma derivative labeled by Grifols Usa, Llc. This kit is formulated for use and contains 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61953001101. 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:

10-Digit Format (5-4-1)
61953-0011-1
11-Digit CMS (5-4-2)
61953-0011-01

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