Catalog Number

SMA13OBBKE

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA13OBBKE

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

OKV

Product Code Name

Obstetrical kit

Public Device Record Key

cb0bb0a4-e1f1-4676-9a9a-26e1851aebe7

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

50888439993156

Quantity per Package

6

Contains DI Package

10888439993158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE