ACTIV.A.C.™ - 300 ml Canister (with Gel) for Activac Therapy - KCI USA, INC.

Duns Number:102726734

Device Description: 300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile

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More Product Details

Catalog Number

-

Brand Name

ACTIV.A.C.™

Version/Model Number

M8275058/5 M8275058/10

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

K063692,K063692,K063692

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

a1e29831-94ed-48de-ac1c-add7b26844f8

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

00849554000940

Quantity per Package

5

Contains DI Package

00849554001992

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