Catalog Number

8888160408

Brand Name

Argyle

Version/Model Number

8888160408

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

Yes

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

5beae8e1-51e9-4b49-a2a1-4081d03cd208

Public Version Date

October 19, 2020

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884527005144

Quantity per Package

5

Contains DI Package

10884527005147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK