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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 29 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REMstar System One 60 Series | REMstar Auto P-Flex, w/Humid, Sys One 60 Srs, FR | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask with EE, Single Patient Use, Small, USA | FDA UDI | Class II | Active |
| DreamStation 2 | DreamStation 2 CPAP w/ Humidifier/Cell/B | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro wiith Humidifier, with WiFi, CA | FDA UDI | Class II | Active |
| Care Orchestrator | 1.17 | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/SE, W/Headgear, Large, JP | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB | FDA UDI | Class II | Active |
| Wisp | 1118067 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP, GB | FDA UDI | Class II | Unknown |
| Millennium M10 | Millennium M10 O2 Percent Ind, Transfill,120V, US/CA | FDA UDI | Class II | Unknown |
| BiPAP A30 | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1 w/ CAPSTRAP, Medium, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T25, No Bluetooth, IN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro with C-Flex, Praxair Spain | FDA UDI | Class II | Active |
| DreamWear | DreamWear Full Mask, S, with S/M Frame, KR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, INTL | FDA UDI | Class II | Active |
| DreamStation Go | ARG502S15 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask, SE, Disposable, Japan, Large | FDA UDI | Class II | Active |
| Nebulizing Elbow | Standard Elbow, Nebulizing Elbow Kit | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, BL | FDA UDI | Class II | Active |
| Af531 | AF531, EE, Leak 1, Neb Elbow, w/4 PT Headgr, SU, Large, US | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with Heated Tube, with SD Slot, AH | FDA UDI | Class II | Active |
| Trilogy | Trilogy 202 Ventilator, China | FDA UDI | Class II | Active |
| DreamStation ST30 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/WiFi, IT | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humid, w/H Tube, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humidifier, w/Cell, AHP | FDA UDI | Class II | Unknown |
| DreamMapper Web (EMEA) | 2.9 | FDA UDI | Class II | Active |
| DreamStation | 01 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, JP | FDA UDI | Class II | Unknown |
| SimplyGo | SimplyGo, FR | FDA UDI | Class II | Active |
| Sensor | PIEZO RESP. EFF. SEN. ADLT. BUCKLE STYLE | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Small, w/Small Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK REUSABLE PACK, LARGE, KOREA | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| Alice 6 | ALICE 6 | FDA UDI | Class II | Active |
| DreamWear | 1137410 | FDA UDI | Class II | Active |
| Circuits | Disposable Pediatric Heated Active Circuit, NO | FDA UDI | Class II | Active |
| Trilogy | Trilogy202 Ventilator, Korea | FDA UDI | Class II | Active |
| Circuits | Disposable Adult Active Circuit no H2O Trap | FDA UDI | Class II | Active |
| Wisp | 1137369 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Auto-Trial, BR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humid w/Heated Tube, CA | FDA UDI | Class II | Active |
| Amara Gel | 00 | FDA UDI | Class II | Active |
| Sensor | NK Piezo Effort 1 CH A Kit | 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