Catalog Number

SPP99DE3AA

Brand Name

CARDINAL HEALTH

Version/Model Number

SPP99DE3AA

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

aa467c81-0b48-4b66-b296-c964e0ded1f2

Public Version Date

May 24, 2022

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

50885425482823

Quantity per Package

3

Contains DI Package

10885425482825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE