Catalog Number

-

Brand Name

MPS

Version/Model Number

5001111

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

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

9301d0fc-41db-410e-a88a-92282fc2fe59

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

November 16, 2020

Package DI Number

20634624500116

Quantity per Package

10

Contains DI Package

00634624500112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-