Catalog Number

-

Brand Name

NA

Version/Model Number

CB10V15R1

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

K891687,K891687

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

671b7051-8384-4c64-b6fe-e8653a56cd2b

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Package DI Number

20763000229195

Quantity per Package

5

Contains DI Package

00763000229184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK