Catalog Number

ORO2300712

Brand Name

CARDINAL HEALTH

Version/Model Number

ORO2300712

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

MLS

Product Code Name

Labor and Delivery Kit

Public Device Record Key

4550febc-409f-40b7-9f28-011351ca92b5

Public Version Date

January 29, 2021

Public Version Number

1

DI Record Publish Date

January 21, 2021

Package DI Number

50195594911537

Quantity per Package

5

Contains DI Package

10195594911539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE