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

CircuFlow - 00879766005204 Catalog Number :

Device Description : 4Chamber Large wide leg garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005211 Catalog Number :

Device Description : 4Chamber Medium arm garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005228 Catalog Number :

Device Description : 4Chamber Large arm garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005235 Catalog Number :

Device Description : 2 Chamber Arterio Flow garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005242 Catalog Number :

Device Description : 4Chamber Medium extra wide leg garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005259 Catalog Number :

Device Description : 4 Chamber Small Extra Wide Leg Garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005266 Catalog Number :

Device Description : Standard Foot garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005273 Catalog Number :

Device Description : Small foot garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005280 Catalog Number :

Device Description : DVT Standard calf garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Cirona - 00879766005297 Catalog Number :

Device Description : DVT Large calf garment

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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