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

V.A.C.® GRANUFOAM™ - 00878237000397 Catalog Number :

Device Description : Vac Granufoam Dressing Medium Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237000670 Catalog Number :

Device Description : Vac Granufoam Dressing Small Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237000700 Catalog Number :

Device Description : Vac Granufoam Bridge Dressing Large Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237000731 Catalog Number :

Device Description : Vac Granufoam Dressing Thin Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237000762 Catalog Number :

Device Description : Vac Granufoam Dressing Round Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. ATS™ - 00878237000830 Catalog Number :

Device Description : 500 ml canister 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.™ - 00878237000892 Catalog Number :

Device Description : 500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

INFOV.A.C.™ - 00878237000922 Catalog Number :

Device Description : 500 ml Canister (without Gel) for Infovac and VAC Ulta Therapy Systems

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. FREEDOM™ - 00878237000977 Catalog Number :

Device Description : Vac Freedom 300ml Canister with Gel

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00878237001080 Catalog Number :

Device Description : Vac Granufoam Hand Dressing Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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