Catalog Number

-

Brand Name

AUTOTRANSFUSION ACCESSORIES

Version/Model Number

COD. 131E

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

K872159,K872159,K872159

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

9db66232-c078-491e-94c0-349ec308c527

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

38033178105478

Quantity per Package

50

Contains DI Package

18033178105474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX