Catalog Number

47-4500

Brand Name

CARDINAL HEALTH

Version/Model Number

47-4500

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

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

d4f66671-53ba-4e26-ba6d-b69983971453

Public Version Date

August 19, 2019

Public Version Number

4

DI Record Publish Date

July 12, 2016

Package DI Number

50885380097599

Quantity per Package

10

Contains DI Package

10885380097591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE