Catalog Number

-

Brand Name

NA

Version/Model Number

CB11A58R

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

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

53e1518a-2f85-4843-a0ea-632cf11f839e

Public Version Date

September 27, 2019

Public Version Number

1

DI Record Publish Date

September 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-