Catalog Number

8888591065

Brand Name

Argyle

Version/Model Number

8888591065

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

3df9c5bd-6801-4e85-b547-bac1aad5bfdd

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

October 06, 2016

Package DI Number

00884521139353

Quantity per Package

10

Contains DI Package

00884521149833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE