Catalog Number

SBA23ECRMD

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA23ECRMD

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)

Yes

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

-

Product Code

OEU

Product Code Name

Cardiopulmonary bypass catheter kit

Public Device Record Key

0e7159e9-a715-4061-a7ff-63a5825f853c

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Package DI Number

50888439140277

Quantity per Package

4

Contains DI Package

10888439140279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE