Catalog Number

70104.3292

Brand Name

ROTAFLOW

Version/Model Number

Console, English/ US

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

K991864

Product Code

KFM

Product Code Name

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Public Device Record Key

4cebb1c1-18c5-48eb-84bc-7247c3a8e971

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-