CARDINAL HEALTH - NPWT PRO and Ally Carry Case - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: NPWT PRO and Ally Carry Case

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More Product Details

Catalog Number

47-9600

Brand Name

CARDINAL HEALTH

Version/Model Number

47-9600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Device Record Status

Public Device Record Key

bc2436da-7b9c-4921-acbf-1a5c72334a5d

Public Version Date

July 05, 2022

Public Version Number

1

DI Record Publish Date

June 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 111