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

Generator, Oxygen, Portable (CAW) (5) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (4) Compressor, Air, Portable (BTI) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

iGo2 - 00885304022237 Catalog Number :

Device Description : Portable oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

iGo2 - 00885304022244 Catalog Number : 125K

Device Description : Portable oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

iGo2 - 00885304022251 Catalog Number : 125A

Device Description : Portable oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022268 Catalog Number : 3655I-AR

Device Description : Compressor/nebulizer

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BTI, CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022282 Catalog Number : 7305D-LA

Device Description : Vacu-Aide Homecare Suction Unit, Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022299 Catalog Number : 7305P-LA

Device Description : Vacu-Aide Homecare Suction Unit w/Battery, Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022305 Catalog Number : 7314D-LA

Device Description : Vacu-Aide QSU, Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022312 Catalog Number : 7314P-LA

Device Description : Vacu-Aide QSU w batterty, Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022466 Catalog Number : 1025DS

Device Description : 10-liter oxygen concentrator

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022480 Catalog Number : 1025UK

Device Description : 10-liter oxygen concentrator (UK Model)

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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