Catalog Number

8888160358

Brand Name

Argyle

Version/Model Number

8888160358

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2021

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

dae88e5c-5d7f-4c02-b3c0-5fffca78ea54

Public Version Date

May 12, 2021

Public Version Number

8

DI Record Publish Date

September 28, 2016

Package DI Number

10884527020522

Quantity per Package

10

Contains DI Package

20884527020529

Package Discontinue Date

May 11, 2021

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK