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) (7) Sleeve, Limb, Compressible (JOW) (3)

Premarket Exempt

Clear

Cirona - 00879766005426 Catalog Number :

Device Description : Deep Vein Thrombosis (DVT) Prevention Therapy

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005433 Catalog Number :

Device Description : Deep Vein Thrombosis (DVT) Prevention THerapy

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005440 Catalog Number :

Device Description : Deep Vein Thrombosis Prevention Therapy

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005464 Catalog Number :

Device Description : 2400 Pump set with a canister in a box

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005471 Catalog Number :

Device Description : 3600 Pump set with one canister in a box

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005495 Catalog Number :

Device Description : 2400 100CC Canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005501 Catalog Number :

Device Description : 2400 400cc Canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005518 Catalog Number :

Device Description : 3600 400cc Canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005525 Catalog Number :

Device Description : 3600 1000cc Canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005532 Catalog Number :

Device Description : Designed to fit the extriCARE 2400 device with a 100cc canister

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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