Catalog Number

SMAOCVDRTD

Brand Name

CARDINAL HEALTH

Version/Model Number

SMAOCVDRTD

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

f34a5a9d-4ae4-4428-812c-b57ca2d79ffc

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

July 19, 2016

Package DI Number

50885425954313

Quantity per Package

6

Contains DI Package

10885425954315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE