Catalog Number

-

Brand Name

NA

Version/Model Number

CB9H04R1

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K891687,K891687

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

9d97e3da-e8ff-4f2b-8ead-409364666b63

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-