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) (6) Nebulizer (Direct Patient Interface) (CAF) (4) Compressor, Air, Portable (BTI) (3)

Premarket Exempt

Yes No

Clear

DeVilbiss - 00885304001102 Catalog Number : DV55D-HH-S

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

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001119 Catalog Number : DV54D-S

Device Description : IntelliPAP AutoAdjust & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001126 Catalog Number : DV54D-HH-S

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

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001133 Catalog Number : DV53D-S

Device Description : IntelliPAP Standard Plus & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001140 Catalog Number : DV53D-HH-S

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

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001157 Catalog Number : DV51D-s

Device Description : IntelliPAP Standard & SmartLink Module & Data Card

Device Class :

Duns Number: 962175894

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001188 Catalog Number : 3655LTPL-REID

Device Description : Compressor / Nebulizer with disposable - Private Label Reid Hospital/Reid@HOME

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001249 Catalog Number : 3655LTPL-DDM

Device Description : Compressor / Nebulizer with disposable - Private Label Discount Drug Mart

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001256 Catalog Number : 3655LTPL-EME

Device Description : Compressor / Nebulizer with disposable - Private Label Ephrata

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

DeVilbiss - 00885304001263 Catalog Number : 3655LTPL-HRC

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

Device Class : 2

Duns Number: 962175894

Premarket Exempt : No

Product Code : CAF, BTI

Prescription Use : Yes

Device Count : 1

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