Catalog Number

70101.8066

Brand Name

ROTAFLOW

Version/Model Number

Centrifugal Pump, USA

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

K991864,K991864

Product Code

KFM

Product Code Name

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Public Device Record Key

04084b48-367c-4e3d-b5aa-6d3541949c63

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

04037691000824

Quantity per Package

10

Contains DI Package

04037691123554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-