Catalog Number

1274.14

Brand Name

VYGON

Version/Model Number

1274.14

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

3339a410-c1cb-4128-bfa1-0fec7fa5a833

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

53660812012206

Quantity per Package

15

Contains DI Package

33660812012202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-