CARDINAL HEALTH - NPWT Ally To Go™ (ATG) - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: NPWT Ally To Go™ (ATG)

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More Product Details

Catalog Number

48-0010

Brand Name

CARDINAL HEALTH

Version/Model Number

48-0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

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

97e8d2f0-a757-4320-a664-bf6c481b48c9

Public Version Date

November 23, 2021

Public Version Number

7

DI Record Publish Date

May 30, 2018

Additional Identifiers

Package DI Number

50885380153042

Quantity per Package

1

Contains DI Package

10885380153044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EACH

"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 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40