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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 58 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pico | Pico Traditional Nasal Mask with Headgear, Sm-Medium, INTL | FDA UDI | Class II | Active |
| Dorma 100, BR | Dorma 100, BR | FDA UDI | Class II | Unknown |
| DreamMapper Web (EMEA) | 2.18 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Expert w/Humid w/H Tube, CA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK REUSABLE PACK, MEDIUM, KOREA | FDA UDI | Class II | Unknown |
| BiPAP AVAPS | BiPAP AVAPS C Series Core Pack, 30cm, CN | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Small, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstarAuto A-Flex w/Humid, w/Bluetooth,60 Srs, AHP | FDA UDI | Class II | Active |
| Trilogy | Trilogy O2 Ventilator Japan | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, with Humidifier, 60 Series, AHP | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW NASAL CANNULA, M-F, 0.45 x 0.40, SINGLE | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Broadband | Broadband Modem, RoHS, EU | FDA UDI | Class I | Unknown |
| Af541 | AF541 Mask EE, Leak 2 with 4 Point Headgear, Small | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with CapStrap, Medium, USA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Li Ion Battery, Ventilation, Japan | 00 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, SA | FDA UDI | Class II | Unknown |
| Af531 | AF531Mask EE, Leak 1, Neb Elbow, 4 PT Headgr, Large, SU | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Large, Leak 3, ASM | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Wide, w/Small Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under the Nose Nasal, FitPack | FDA UDI | Class II | Active |
| Wisp | 1137360 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube, w/Cell, AHP | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/Humid, System One 60 Srs, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory with Oximetry, US | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, US | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, FI | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro w/BlueTooth, CA | FDA UDI | Class II | Active |
| Af541 | AF541 Mask,SE, Under Nose, 4 PT HEADGEAR, SIZE B | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| Pico | Pico Traditional Nasal Mask without Headgear, Sm-Medium | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30 AAM no Bluetooth, BR | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask with EE, Leak 2, Single Use, Xlarge | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.34 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Therapy Mask 3100 | Small, Therapy Mask 3100 Silicone Pillow | FDA UDI | Class II | Active |
| Amara | Amara Mask with SE, Large, with RS Frame and Headgear, INTL | FDA UDI | Class II | Active |
| Af811 | AF811 w/Filtered Exhal Port Procedure Pack, Sm SA | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, M, S Frame with Headgear, Global | FDA UDI | Class II | Active |
| Tubing Quick Release | 00 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, LEAK 1, with CapStrap, Small, Single Use | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, with 4 PT Headgear, Medium, USA | FDA UDI | Class II | Unknown |
| zRIP | zRIP Sum RT Module | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak SE Mask w/Headgear, Disp, Medium, USA | FDA UDI | Class II | Active |
| Pico | PICO NASAL MASK W/Headgear, Large, JP | FDA UDI | Class II | Unknown |
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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