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) (10)

Premarket Exempt

No Yes

Clear

DeVilbiss - 00885304022060 Catalog Number : DV51D-LA

Device Description : IntelliPAP Standard - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022077 Catalog Number : DV53D-LA

Device Description : IntelliPAP Standard - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022084 Catalog Number : DV54D-LA

Device Description : IntelliPAP Auto Adjust - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022091 Catalog Number : DV55D-LA

Device Description : IntelliPAP Bilevel S - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022107 Catalog Number : DV57D-LA

Device Description : IntelliPAP auto bilevel - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022114 Catalog Number : DV51D-HH-LA

Device Description : IntelliPAP Standard with Heated Humidifier - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022121 Catalog Number : DV53D-HH-LA

Device Description : IntelliPAP Standard Plus w/HH - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022138 Catalog Number : DV54D-HH-LA

Device Description : IntelliPAP AutoAdjust with Heated Humidifier - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022145 Catalog Number : DV55D-HH-LA

Device Description : IntelliPAP Bilevel S w/HH - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304022152 Catalog Number : DV57D-HH-LA

Device Description : IntelliPAP AutoBilevel w/HH - Latin America

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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