DEVILBISS HEALTHCARE LLC

Address:100 Devilbiss Dr,SOMERSET,PA,15501,US

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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

Nebulizer (Direct Patient Interface) (CAF) (5) Generator, Oxygen, Portable (CAW) (4) Compressor, Air, Portable (BTI) (1)

Premarket Exempt

Yes No

Clear

DeVilbiss - 00885304000846 Catalog Number : 525DS

Device Description : 5-liter oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss iFill - 00885304000853 Catalog Number : 535D

Device Description : Portable Oxygen Station

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss iFill - 00885304000860 Catalog Number : 535I

Device Description : Portable Oxygen Station

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000877 Catalog Number : 5650D

Device Description : PULMO-AIDE

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000884 Catalog Number : 5650C

Device Description : PULMO-AIDE CANADA

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000891 Catalog Number : 5650F

Device Description : PULMO-AIDE - France

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000907 Catalog Number : 5650I

Device Description : PULMO-AIDE - International

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000921 Catalog Number : 5650P

Device Description : PULMO-AIDE - Philippines

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000938 Catalog Number : 4650D

Device Description : Compressor / Nebulizer

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000976 Catalog Number : 525KS

Device Description : 5-liter oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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