Catalog Number

8888577775

Brand Name

Argyle

Version/Model Number

8888577775

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

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

ac3bd5d2-c9b9-43d5-9868-0106b9865bb0

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521124544

Quantity per Package

40

Contains DI Package

10884521124547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE