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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 22 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REMstar System One 60 Series | REMstar Auto A-Flex System One 60 Series LA | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, LEAK 1, Under Nose, 4-PT HEADGR, INTL, SIZE A | FDA UDI | Class II | Active |
| PerformaTrak | Capstrap with FEP Procedure Pack, Large, SA | FDA UDI | Class II | Unknown |
| Alice PDx | Alice PDx ECG Yoke, JP | FDA UDI | Class II | Unknown |
| Optilife | 00 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with Capstrap, Medium, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto CPAP w/Humid w/H Tube, AHP | FDA UDI | Class II | Unknown |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Petite, USA | FDA UDI | Class II | Active |
| Sensor | PEDIATRIC VELCRO STRAP KIT 1.5" | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, with 4 Point Headgear, XLarge | FDA UDI | Class II | Active |
| DreamStation | DreamStation ST 30 with Heated Humidifier, AAM, ND | FDA UDI | Class II | Active |
| EverFlo | EVERFLO NON-O2 Percentage Indicator 120V, LA | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, SE | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, M Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, EU | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, BL | FDA UDI | Class II | Active |
| CoughAssist | 00 | FDA UDI | Class II | Active |
| Performax | PERFORMAX Pediatric EE, LEAK 1 ELBOW, Single Use | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, ZA | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Clear Frame, without headgear, Small/Medium, US | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, XL, Sm/Med Connector, W/Headgear, KR | FDA UDI | Class II | Unknown |
| System One 60 Series | REMstar Plus, INTL | FDA UDI | Class II | Active |
| Dorma 200 | 00 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+ System One, 60 Series, FR | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation CPAP Pro w/Humidifier, w/WiFi, US | FDA UDI | Class II | Active |
| DreamStation 2 | DreamStation 2 Advanced CPAP with Humidifier, Cellular, Bluetooth for BL | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One, 60 Series, INTL | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Upgrade, LDx, US | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, JP | FDA UDI | Class II | Unknown |
| Trilogy 200 | Trilogy 200 Ventilator, Japan-Recert | FDA UDI | Class I | Unknown |
| Care Orchestrator | 1.14 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, JPN, Child Large, Leak 3, Single Use | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini, Standard Battery, JP | FDA UDI | Class II | Unknown |
| Bluetooth | Bluetooth Accessory Module, US | FDA UDI | Class I | Active |
| Amara Gel | AMARA GEL MASK WITH RS FRAME AND HEADGEAR INTL, SMALL | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.14 | FDA UDI | Class II | Active |
| Dorma 101, ZA | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, EE | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask w/Headgear, Medium, Disposable, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem, US | FDA UDI | Class I | Active |
| DreamWear Full | DreamWear Full Mask Medium Wide, w/Large Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Trilogy | RTO1054260B | FDA UDI | Class II | Active |
| Sensor | External Flow Sensor Cable | FDA UDI | Class II | Active |
| CoughAssist | 00 | 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