OAKWELL DISTRIBUTION, INC.

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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

Clear

extriCARE - 00879766005546 Catalog Number :

Device Description : Designed to fit the extriCARE 2400 device with a 400cc canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005556 Catalog Number :

Device Description : Designed to fit the extriCARE 3600 device with a 400cc canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005563 Catalog Number :

Device Description : Designed to fit the extriCARE3600 device with a 1000cc canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005570 Catalog Number :

Device Description : EC2400 adapter without the snap-on plug

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005587 Catalog Number :

Device Description : EC2400 adaper with US

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005600 Catalog Number :

Device Description : NPWT Bandage-Large oval tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005617 Catalog Number :

Device Description : NPWT Bandage-Small oval tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005624 Catalog Number :

Device Description : NPWT Bandage- Sacrum with tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005631 Catalog Number :

Device Description : NPWT Bandage-Foot with tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005648 Catalog Number :

Device Description : NPWT Bandage-Mini oval with tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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