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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 34 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alice 6 | Alice 6 LDxS Headbox, Brazil | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/H Tube Humid, w/St Tube, 60 Srs, CA | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series Circuit, Trach, 6ft | FDA UDI | Class II | Active |
| DreamStation BiPAP S/T | DreamStation BiPAP S/T30 w/ Humidifier, ES | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, w/HT Humid, St Tube, 60 Series, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30, no Bluetooth, AAM, BR | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Full Mask w/SE, Medium, JP | FDA UDI | Class II | Unknown |
| PerforMax | PerforMax Mask w/SE, Plus 4 PT HDGR, MPU, INTL, XL | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.40 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.19 | FDA UDI | Class II | Active |
| Circuits | Invasive Circuit Assembly | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, INTL | FDA UDI | Class II | Active |
| Millennium M10 | Millennium M10 Concentrator, US | FDA UDI | Class II | Active |
| Wisp | 1118066 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| PerformaTrak | CapStrap with FEP Procedure Pack, Small, SA | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced with Humidifier, 60 Series, 30cm | FDA UDI | Class II | Unknown |
| Pn841 | PN841 Mask, JPN, Child Large, SE, Single Use | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME w/o Headgear, Medium, US | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.33 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem, Flagship, US | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/HT Humid System One 60Series, JP | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, Med Frame w/Headgear, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP, FR | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex with Humidifier System One 60 Series,FI | FDA UDI | Class II | Active |
| BiPAP ST | BiPAP S/T C Series, 30CM, ND | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| Dorma | Dorma 100 with Humidifier, LA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Auto-Trial, w/Humid, w/H Tube,CN | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.35 | FDA UDI | Class II | Active |
| Circuits | Disposable Pediatric Passive Circuit with H2O Trap | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with Capstrap, X-Large | FDA UDI | Class II | Active |
| Bluetooth | Bluetooth Accessory Module, INTL | FDA UDI | Class I | Active |
| BiPAP AVAPS | BIPAP AVAPS C Series, 30cm, AU | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist, E70, JP | FDA UDI | Class II | Unknown |
| DreamWear | 1137400 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Small, International | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, TR | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidifier, ES | FDA UDI | Class II | Active |
| Care Orchestrator | 1.5 | FDA UDI | Class II | Active |
| Trilogy | Trilogy200 Ventilator, Latin America | FDA UDI | Class II | Active |
| Bluetooth Accessory | 00 | FDA UDI | Class I | Active |
| Wisp | Wisp Nasal Mask w/Headgear, Fabric Frame, Sm/Med, JP | FDA UDI | Class II | Unknown |
| DreamStation BiPAP ST30 | 00 | FDA UDI | Class II | Active |
| DreamWear | 1137389 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, BR | 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