3M™ Vac® - 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US - KCI USA, INC.

Duns Number:102726734

Device Description: 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US

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More Product Details

Catalog Number

CAPULTDEV01/US

Brand Name

3M™ Vac®

Version/Model Number

CAPULTDEV01/US

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

17b7ab14-d3e0-4033-b41f-e56b6a640971

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KCI USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 63