Respironics, Inc.

Address:920 SW Emkay Drive, Suite 100,Bend,OR,97702,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) Continuous, ventilator, home use (NOU) (2) Ventilator, continuous, facility use (CBK) (2) Ventilator, continuous, minimal ventilatory support, facility use (MNT) (1) Ventilator, continuous, non-life-supporting (MNS) (1)

Premarket Exempt

No Yes

Clear

Pico - 00606959062511 Catalog Number : 1104940MY

Device Description : Small Medium Large Extra Large Pico Fitpack with Headgear Malaysia

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear Full - 00606959062528 Catalog Number : 1135277

Device Description : Small Wide, DreamWear Full, Small and Medium Frame, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear Full - 00606959062535 Catalog Number : 1135278

Device Description : Medium Wide, DreamWear Full, Small and Medium Frame, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959062757 Catalog Number : FRX521H14C

Device Description : DreamStation 2 ADVANCED Auto CPAP device with Humidifier, Flex Features, Cellula DreamStation 2 ADVANCED Auto CPAP device with Humidifier, Flex Features, Cellular Bluetooth Connectivity for France

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959062818 Catalog Number : BLX520H15C

Device Description : DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959062825 Catalog Number : BLX420H15C

Device Description : DreamStation 2 Advanced CPAP with Humidifier, Cellular, Bluetooth for BL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959062832 Catalog Number : BLX510H15C

Device Description : DreamStation 2 Auto CPAP with Humidifier, Cellular, and Bluetooth for BL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959062849 Catalog Number : BLX410H15C

Device Description : DreamStation 2 CPAP with Humidifier, Cellular, and Bluetooth for BL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Care Orchestrator Essence - 00606959062863 Catalog Number : 1135709

Device Description : Care Orchestrator Essence, Medical equipment clinical data interfacing software

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK, BZD, NOU, MNS, MNT

Prescription Use : Yes

Device Count : 1

Aeris Evo - 00606959062962 Catalog Number : VT2110X24B

Device Description : Aeris Evo Ventilator

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : NOU, CBK

Prescription Use : Yes

Device Count : 1

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