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

Ventilator, Non-Continuous (Respirator) (BZD) (4) Generator, Oxygen, Portable (CAW) (3) Compressor, Air, Portable (BTI) (2) Nebulizer (Direct Patient Interface) (CAF) (2) Bottle, Collection, Vacuum (KDQ) (1)

Premarket Exempt

No Yes

Clear

DeVilbiss - 00885304009481 Catalog Number : 3655PL-S4H

Device Description : Compressor / Nebulizer - 3655PL-S4H

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009498 Catalog Number : 3655LTPL-SME

Device Description : Compressor / Nebulizer with disposable - Private Label Shan Medical Equipment

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009504 Catalog Number : DV53D-HH-S2

Device Description : IntelliPAP Standard Plus w/HH & Smartlink II, Module & Data

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009511 Catalog Number : DV54D-HH-S2

Device Description : IntelliPAP AutoAdjust w/HH & SmartLink II

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009528 Catalog Number : DV55D-HH-S2

Device Description : IntelliPAP Bilevel S w/HH & SmartLink II, Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009535 Catalog Number : DV57D-HH-S2

Device Description : IntelliPAP AutoBilevel w/HH & SmartLink II, Module & Data Ca

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304009634 Catalog Number : 7305AP-632

Device Description : Disposable Suction Canister for Japan

Device Class : 2

Duns Number: 962175894

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : No

Device Count : 1

DeVilbiss - 00885304009689 Catalog Number : 525DS-Q

Device Description : 5-liter oxygen concentrator - Quiet Unit

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304010074 Catalog Number : 535D-M6-870

Device Description : M6 CYL W/IFILL POST ADAPTER, W/870 POST VALVE

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304011026 Catalog Number : 535I-ML6-CF

Device Description : ML6 CYLINDER W/CF REG EUROPE

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

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