Catalog Number

-

Brand Name

NA

Version/Model Number

BB7X32R12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 2018

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

K973011

Product Code

KFM

Product Code Name

Pump, blood, cardiopulmonary bypass, non-roller type

Public Device Record Key

e8a49797-04c1-4500-ae64-2e7982804ba5

Public Version Date

December 24, 2018

Public Version Number

4

DI Record Publish Date

May 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-