KCI USA, INC.

Address:12930 IH 10 West,San Antonio,TX,78249,US

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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) Negative Pressure Wound Therapy Non-Powered Suction Apparatus (OKO) (1) negative pressure wound therapy Powered suction pump (OMP) (1)

Premarket Exempt

No Yes

Clear

V.A.C.RX4 - 00849554004764 Catalog Number :

Device Description : V.A.C.RX4 Therapy System

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA RESTOR ROTO•FORM™ - 00849554004771 Catalog Number : PRE5655

Device Description : PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ V.A.C.® - 00849554004979 Catalog Number :

Device Description : Prevena VAC Connector

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. ® - 00849554005020 Catalog Number :

Device Description : VAC Drape XL

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. DERMATAC™ - 00849554005242 Catalog Number :

Device Description : V.A.C. DERMATAC™ DRAPE

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA PLUS™ CUSTOMIZABLE™ - 00849554005303 Catalog Number :

Device Description : Prevena Plus Customizable Dressing with Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA PLUS™ - 00849554005310 Catalog Number :

Device Description : Prevena Plus 150 ml Canister

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA PLUS™ - 00849554005358 Catalog Number :

Device Description : Prevena Plus Incision Management System

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ PEEL & PLACE™ - 00849554005389 Catalog Number :

Device Description : Prevena Peel & Place System Kit- 13 cm

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

SNAP™ - 00849554005402 Catalog Number :

Device Description : Snap Therapy System Snap Bridge Dressing Kit14 cm X 11 cm Bridge Dressing Kit8 c Snap Therapy System Snap Bridge Dressing Kit14 cm X 11 cm Bridge Dressing Kit8 cm X 8 cm Foam

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

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