Catalog Number

-

Brand Name

Quantum PureFlow Centrifugal Blood Pump CP37

Version/Model Number

CP37V-V0

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)

Yes

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

K192850,K202169,K192850,K202169

Product Code

KFM

Product Code Name

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Public Device Record Key

a7ee15b0-5c81-4d5d-b86c-ff8d3efdb145

Public Version Date

August 09, 2021

Public Version Number

3

DI Record Publish Date

April 27, 2020

Package DI Number

28051160300611

Quantity per Package

5

Contains DI Package

08051160300617

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple carton box