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 - 00879766005655 Catalog Number :

Device Description : NPWT Bandage-Extra large oval with tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005662 Catalog Number :

Device Description : NPWT Foam kit-Large

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005679 Catalog Number :

Device Description : NPWT Foam kit-Small

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005693 Catalog Number :

Device Description : EC 2400 adapter with UK

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005716 Catalog Number :

Device Description : UK type snap-on plug for EC2400 adapter

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005723 Catalog Number :

Device Description : extriCARE large oval dressing

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005730 Catalog Number :

Device Description : extriCARE Small oval dressing

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005747 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 - 00879766005754 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 - 00879766005761 Catalog Number :

Device Description : Mini oval bandage 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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