V.A.C. FREEDOM™ - Vac Freedom 300ml Canister with Gel - KCI USA, INC.

Duns Number:102726734

Device Description: Vac Freedom 300ml Canister with Gel

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More Product Details

Catalog Number

-

Brand Name

V.A.C. FREEDOM™

Version/Model Number

320058/5 320058/10

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

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 Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

73e6d3fe-2e8b-40ca-a564-2bd21de8a6dd

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

00878237000953

Quantity per Package

5

Contains DI Package

00878237000977

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Pack

"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