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Sign in to claim this brandRespironics, Inc.
United States·US-MF-000002301
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1001, Murry Ridge Lane, Murrysville, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Melissa Rosko
- EUDAMED SRN
- US-MF-000002301
- FDA FEI Number
- 3007220521
- DUNS Number
- 080728314
Catalogue (3774)
Page 53 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP A40 | NDX3100T19 | FDA UDI | Class II | Active |
| Circuits | Adult Non-Invasive Passive Disposable Non-Heated Circuit | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA | FDA UDI | Class II | Active |
| RUSleeping RTS | RUSLEEPING RTS | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Heated Tube, LA | FDA UDI | Class II | Unknown |
| Af541 | AF541Mask, EE, Leak 2, UnderNose, w/CAPSTRAP, SIZE A | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30CM, FR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory, US | FDA UDI | Class I | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Large, USA | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, 60 Series, CA | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier without Tube, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Expert w/Humidifier, w/Cell, CA | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro, CN | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series Core Pack, 30cm, CN | FDA UDI | Class II | Unknown |
| Performax | PERFORMAX Mask with EE, Leak 2, XSmall, Single Use | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask w/SE, Single Use, Extra Large | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Clear Frame, with magnetic clips, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex System One 60 Series US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, KR | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask with Standard Elbow, WITH CAPSTRAP, MEDIUM | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro, Bluetooth, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex with Humidifier, 60 Series, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with C-Flex, AR | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem with Oximetry, JP | FDA UDI | Class I | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+ w/ Humid, System One 60 Series, CN | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series, 25cm, INTL | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.31 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, Adapter, 22mm x 22mm | FDA UDI | Class II | Active |
| Trilogy | Trilogy Passive Exhalation Circuit, Pediatric | FDA UDI | Class II | Active |
| BiPAP A40 | GBX3H | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with Standard Elbow, WITH CAPSTRAP, LARGE | FDA UDI | Class II | Active |
| Amara Gel | 00 | FDA UDI | Class II | Active |
| Dorma | Dorma 200, AU | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series, Mouthpiece | FDA UDI | Class II | Active |
| Millennium M10 | Millennium M10 Transfill,120V, US, CA | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/H Tube Humid, St Tube, 60 Series, CA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, P, S-M-L Connector w/Hdgr, JN | FDA UDI | Class II | Active |
| DreamStation | DreamStation Nonin SpO2 Cable | FDA UDI | Class II | Active |
| Plateau | Plateau Exhalation Valve (PEV), Single, Reusable | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, ES | FDA UDI | Class II | Active |
| Trilogy | Trilogy100 Ventilator, United States | FDA UDI | Class II | Active |
| DreamWear | 1137439 | FDA UDI | Class II | Active |
| Dorma | Dorma 500 Auto, LA | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, Petite, Med Connector w/Headgear, Global | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Respironics, Inc. Coyol Alajuela · CR FEI 3027553886