Catalog Number

-

Brand Name

Quantum PureFlow Centrifugal Blood Pump CP22

Version/Model Number

CP22V-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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

K202169,K202169

Product Code

KFM

Product Code Name

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Public Device Record Key

768aca3e-de45-4e71-8384-e9c5064e3783

Public Version Date

August 09, 2021

Public Version Number

3

DI Record Publish Date

April 27, 2020

Package DI Number

28051160300604

Quantity per Package

5

Contains DI Package

08051160300600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton multiple box