Catalog Number

-

Brand Name

MPS Console

Version/Model Number

5001000

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

-

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

K953838

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

59523eed-d70f-40e7-836a-1785514b6ad6

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-