Catalog Number

SBA23AWMUA

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA23AWMUA

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"

Yes

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

-

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

f781d323-0d0e-4ac0-92f4-a72c7852bec2

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 27, 2016

Package DI Number

50887488435150

Quantity per Package

10

Contains DI Package

10887488435152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE