Catalog Number

VY-MAX

Brand Name

VYGON

Version/Model Number

VY-MAX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OWL

Product Code Name

Peripheral catheter insertion kit

Public Device Record Key

c4b0d3e2-e925-4d41-8b7e-fda8296a5204

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Package DI Number

30849884005753

Quantity per Package

4

Contains DI Package

00849884005752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-