Catalog Number

-

Brand Name

MPS 3 Blood Bypass Tubing

Version/Model Number

5301016

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

K200438,K200438

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

eec61644-285f-45e9-8078-b2dd07544858

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

July 27, 2020

Package DI Number

20634624531165

Quantity per Package

5

Contains DI Package

00634624531161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-