Catalog Number

8888160838

Brand Name

Argyle

Version/Model Number

8888160838

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

a63fce7f-91bc-4f0d-be5f-9c16b84ab67b

Public Version Date

April 06, 2020

Public Version Number

10

DI Record Publish Date

September 24, 2016

Package DI Number

20884527005212

Quantity per Package

5

Contains DI Package

10884527005215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE