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) (7) Ventilator, Continuous, Non-Life-Supporting (MNS) (2) Compressor, Air, Portable (BTI) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

Yes No

Clear

DeVilbiss - 00885304001003 Catalog Number : 9352l

Device Description : Serenity Mask, Silicone - Large

Device Class : 2

Duns Number: 962175894

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001010 Catalog Number : 9354GL

Device Description : FlexSet Mask, Large, Gel

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001027 Catalog Number : 9352lr

Device Description : Serenity Mask, ComfortTouch, Silicone - Large

Device Class : 2

Duns Number: 962175894

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001034 Catalog Number : 9354GLR

Device Description : FlexSet Mask, Large, ComfortTouch Gel

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001041 Catalog Number : 3655LTPL-THED

Device Description : Compressor / Nebulizer with disposable - Private Label Theda Care at Home

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001058 Catalog Number : DV57D-S

Device Description : IntelliPAP AutoBilevel & SmartLink Module & Data Card

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001065 Catalog Number : DV57D-HH-S

Device Description : IntelliPAP AutoBilevel w/HH & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001072 Catalog Number : DV56D-S

Device Description : IntelliPAP Bilevel ST & SmartLink Module & Data Card

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : MNS

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001089 Catalog Number : DV56D-HH-S

Device Description : IntelliPAP Bilevel ST w/HH & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : MNS

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001096 Catalog Number : DV55D-S

Device Description : IntelliPAP Bilevel S & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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