Catalog Number

1270.04

Brand Name

VYGON

Version/Model Number

1270.04

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

54d1919f-1233-4040-8898-4019af8c3233

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

53660812012152

Quantity per Package

9

Contains DI Package

33660812012158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-