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) (8) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (1) Compressor, Air, Portable (BTI) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

DeVilbiss - 00885304000228 Catalog Number : DV57UK-HH

Device Description : SLEEPCUBE AUTOBILEVEL W/ HH

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000235 Catalog Number : 3655LTPL-VITA

Device Description : Compressor / Nebulizer with disposable - Private Label Vitas HME Solution

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000266 Catalog Number : 9352sr

Device Description : Serenity Mask, ComfortTouch, Silicone - Small

Device Class : 2

Duns Number: 962175894

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000273 Catalog Number : 9352gsr

Device Description : Serenity Mask, ComfortTouch, Gel, Small

Device Class : 2

Duns Number: 962175894

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000303 Catalog Number : 9354sr

Device Description : FlexSet Comfort Touch Silicone mask size S

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000310 Catalog Number : 9354GSR

Device Description : FlexSet Mask, ComfortTouch, Gel, Small

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000327 Catalog Number : 7314P-D

Device Description : Vacu-Aide QSU w/ Battery, North America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000341 Catalog Number : DV57BR-HH

Device Description : SLEEPCUBE AUTOBILEVEL W/HH BRAZIL

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000358 Catalog Number : DV57BR

Device Description : SLEEPCUBE AUTOBILEVEL BRAZIL

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000365 Catalog Number : DV51BR

Device Description : IntelliPAP Standard - Brazil

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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