Catalog Number

270.03

Brand Name

VYGON

Version/Model Number

270.03

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FOS

Product Code Name

CATHETER, UMBILICAL ARTERY

Public Device Record Key

f46166c1-6be1-44a1-afe2-56fde5bbd5c2

Public Version Date

April 29, 2022

Public Version Number

1

DI Record Publish Date

April 21, 2022

Package DI Number

53660812128839

Quantity per Package

15

Contains DI Package

33660812128835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case