CARDINAL HEALTH - SVEDMAN Wound Treatment System - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: SVEDMAN Wound Treatment System

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More Product Details

Catalog Number

6700032

Brand Name

CARDINAL HEALTH

Version/Model Number

6700032

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2020

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"

Yes

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

e3c03f88-db29-4cbf-9319-7f8b78ec801f

Public Version Date

April 30, 2020

Public Version Number

5

DI Record Publish Date

July 12, 2016

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 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