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

Sleeve, Limb, Compressible (JOW) (10)

Premarket Exempt

Clear

Cirona - 00879766005303 Catalog Number :

Device Description : DVT Extra large calf garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005310 Catalog Number :

Device Description : DVT Extra large calf garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005327 Catalog Number :

Device Description : DVT Small thigh garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005334 Catalog Number :

Device Description : DVT Large thigh garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005341 Catalog Number :

Device Description : DVT Extra large thigh garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : No

Device Count : 1

CircuFlow - 00879766005358 Catalog Number :

Device Description : Sequential compression pump

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : No

Device Count : 1

CircuFlow - 00879766005372 Catalog Number :

Device Description : Sequential compression pump

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005389 Catalog Number :

Device Description : Sequential compression pump

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ArterioFlow - 00879766005402 Catalog Number :

Device Description : Intermittent Circulator

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ArterioFlow - 00879766005419 Catalog Number :

Device Description : Intermittent Circulator

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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