Catalog Number

-

Brand Name

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors

Version/Model Number

CP22V-VT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201320

Product Code

KFM

Product Code Name

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Public Device Record Key

041e784f-ed3e-4534-b0db-51af7753b6cd

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-