KCI USA, INC.

KCI USA, INC.

Address:6203 FARINON DR.,SAN ANTONIO,TX,78249,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (10)

Premarket Exempt

No Yes

Clear

PREVENA™ PEEL & PLACE™ - 00849554000018 Catalog Number :

Device Description : Prevena Peel & Place Dressing- 20 cm Prevena Patch Strips

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ - 00849554000032 Catalog Number :

Device Description : Prevena 45 ml canister

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ CUSTOMIZABLE™ - 00849554000056 Catalog Number :

Device Description : Prevena Incision Management System- Customizable Dressing

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ CUSTOMIZABLE™ - 00849554000087 Catalog Number :

Device Description : Prevena Customizable Dressing

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ PEEL & PLACE™ - 00849554000117 Catalog Number :

Device Description : Prevena Incision Management System- Peel & Place Dressing

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

ABTHERA™ - 00849554000247 Catalog Number :

Device Description : ABTHERA CANISTER

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 20

ACTIV.A.C.™ - 00849554000285 Catalog Number :

Device Description : Activac Therapy System

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

ABTHERA™ - 00849554000407 Catalog Number :

Device Description : Abthera Active Abdominal Therapy

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.ULTA™ - 00849554000636 Catalog Number :

Device Description : VAC ULTA THERAPY SYSTEM

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. WHITEFOAM™ - 00849554000797 Catalog Number :

Device Description : VAC Whitefoam Dressing Small Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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