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) (5) Generator, Oxygen, Portable (CAW) (2) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (1) Compressor, Air, Portable (BTI) (1) Conserver, Oxygen (NFB) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

DeVilbiss - 00853040002806 Catalog Number : 9354DR

Device Description : FlexSet Comfort Touch Silicone mask size M

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00853040015080 Catalog Number : 3655PL-JCMH

Device Description : Compressor / Nebulizer JCMH Home Health Products

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00853040023382 Catalog Number : 7305D-D

Device Description : Homecare Suction, North America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00853040026352 Catalog Number : 535D-E-870

Device Description : E 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 - 00853040037792 Catalog Number : DV5HH

Device Description : Heater, Humidifier

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00853040087988 Catalog Number : DV57D-HH-S-HT

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

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00853040224734 Catalog Number : 1025KS

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

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00855304002577 Catalog Number : PD1000

Device Description : Oxygen PulseDose Conserver

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000037 Catalog Number : DV54SE-P

Device Description : Sleepcube AutoPlus with SmartFlex SE

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304000044 Catalog Number : DV54NE-P

Device Description : SLEEP CUBE AUTO PLUS NORTHERN EUROPE

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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