Respironics, Inc.

Address:6501 Living Place,Pittsburgh,PA,15206,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) (9) Ventilator, Non-Continuous (Respirator) (BZD) (1)

Premarket Exempt

No Yes

Clear

DreamWear - 00606959062153 Catalog Number : 1146469RC

Device Description : DreamWear Silicone Pillows, FitPack, Russian Corridor

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959062207 Catalog Number : LAX600H15C

Device Description : DreamStation BiPAP Pro with Humidifier and Cellular, Latin America

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation Auto BiPAP wHumCell, LA - 00606959062214 Catalog Number : LAX700H15C

Device Description : DreamStation Auto BiPAP with Humidifier and Cellular, Latin America

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959062221 Catalog Number : ARX200H15C

Device Description : DreamStation CPAPwith Humidifier and Cell, AR

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062429 Catalog Number : 1148932

Device Description : DreamWear Under the Nose Silicone Pillows Frame Kit Small

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062436 Catalog Number : 1148933

Device Description : DreamWear Under the Nose Silicone Pillows Frame Kit Medium

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062443 Catalog Number : 1148934

Device Description : DreamWear Under the Nose Silicone Pillows Frame Kit Large

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Pico - 00606959062481 Catalog Number : 1104921MY

Device Description : Small Medium Pico Nasal Mask with Headgear Malaysia

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Pico - 00606959062498 Catalog Number : 1104922MY

Device Description : Large Pico Nasal Mask with Headgear Malaysia

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Pico - 00606959062504 Catalog Number : 1104923MY

Device Description : Extra Large Pico Nasal Mask with Headgear Malaysia

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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