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) (10)

Premarket Exempt

No Yes

Clear

3M™ Veraflo™ Cleanse Choice Complete™ - 00849554008151 Catalog Number : VFCCC05LG

Device Description : 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit Large

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

3M™ Vac® - 00849554008243 Catalog Number : ULTDEV01/US

Device Description : 3M™ Vac® Ulta Therapy Unit ULTDEV01/US

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

3M™ Vac® - 00849554008366 Catalog Number : CAPULTDEV01/US

Device Description : 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

3M™ Prevena Restor™ Adaptiform™ - 00849554008373 Catalog Number : PRE6055

Device Description : 3M™ Prevena Restor™ Adaptiform™ Dressing 5-pack

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009011 Catalog Number : DTGF05PKS

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ SMALL DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 5

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009028 Catalog Number : DTGF05PKM

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ MEDIUM DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 5

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009035 Catalog Number : DTGF05PKL

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ LARGE DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 5

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009042 Catalog Number : DTGF10PKS

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ SMALL DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009059 Catalog Number : DTGF10PKM

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ MEDIUM DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - 00849554009066 Catalog Number : DTGF10PKL

Device Description : DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ LARGE DRESSING

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

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