KCI USA, INC.

Address:12930 IH 10 West,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) (8)

Premarket Exempt

No Yes

Clear

V.A.C.INSTILL® - 00878237001639 Catalog Number :

Device Description : V.A.C. Instill Irrigation Set

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® - 00878237001646 Catalog Number :

Device Description : V.A.C. DRAPE

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. ATS™ - 00878237001677 Catalog Number :

Device Description : 500 ml canister (with Gel) for VAC ATS Therapy Systems

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

INFOV.A.C. ™ - 00878237001738 Catalog Number :

Device Description : Infovac Therapy System

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

ACTIV.A.C. ™ - 00878237001813 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

V.A.C.® SIMPLACE™ - 00878237007808 Catalog Number :

Device Description : VAC Simplace Dressing Medium Featuring Granufoam Spiral Dressing

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® SIMPLACE™ - 00878237007815 Catalog Number :

Device Description : VAC Simplace Dressing Small Featuring Granufoam Spiral Dressing

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237007846 Catalog Number :

Device Description : Vac Granufoam Bridge Dressing

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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