OAKWELL DISTRIBUTION, INC.

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) (9) Pump, Breast, Powered (HGX) (1)

Premarket Exempt

No

Clear

Nature's Bond - 00879766003590 Catalog Number :

Device Description : Premium Breastfeeding Pump

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : HGX

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005013 Catalog Number :

Device Description : 8 Chamber Medium Arm Garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005020 Catalog Number :

Device Description : 8 Chamber Medium arm & shoulder garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005037 Catalog Number :

Device Description : 8 Chamber Large arm garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005044 Catalog Number :

Device Description : 8 Chamber Large arm & shoulder garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005051 Catalog Number :

Device Description : 8 Chamber Small leg garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005068 Catalog Number :

Device Description : Small wide leg garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005075 Catalog Number :

Device Description : 8 Chamber Medium leg garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005082 Catalog Number :

Device Description : 8Chamber Medium wide leg garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

CircuFlow - 00879766005099 Catalog Number :

Device Description : 8 Chamber Large leg garment

Device Class :

Duns Number: 033337813

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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