Catalog Number

-

Brand Name

MPS 3 Delivery Set w/AA w/305cm Line (16C)

Version/Model Number

5163102

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

43219e8d-f14c-4f98-adc4-53dae4f252d1

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

July 27, 2020

Package DI Number

20634624516315

Quantity per Package

10

Contains DI Package

00634624516311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-