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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 51 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP A40 | ITX3H | FDA UDI | Class II | Active |
| PerformaTrak | Entrainment Elbow Starter Kit, Base Package | FDA UDI | Class II | Active |
| OmniLab Connect | OmniLab Connect System, BR | FDA UDI | Class I | Unknown |
| Trueblue | 00 | FDA UDI | Class II | Active |
| Sensor | GRASS Piezo Effort 1 CH P Kit | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, with Capstrap, Large, JP | FDA UDI | Class II | Unknown |
| Trilogy | Trilogy 200 Ventilator, U.S.A.-Rental | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxN Headbox, INTL and Brazil | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Large, Leak 3, Single Use | FDA UDI | Class II | Active |
| Care Orchestrator Netherlands | 1.12 | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| Pro-Tech | AIRFLOW SENSOR THERMOCOUPLE | FDA UDI | Class II | Active |
| Trueblue | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Expert w/Humidifier, w/WiFi, CA | FDA UDI | Class II | Active |
| Sensor | FiO2 Sensor Assembly | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Large, w/Medium Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with Standard Elbow, WITH CAPSTRAP, X-LARGE | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM TR | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, LEAK 1, Under Nose, CAPSTRAP, INTL, SIZE B | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| DreamWear | 1137408 | FDA UDI | Class II | Active |
| DreamWear | 1137437 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Med, SE, Single Use | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One, 60 Series, JP | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.31 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, ES | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Clear Frame, with Headgear, China | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Humidifier, EU | FDA UDI | Class II | Active |
| Trueblue | 00 | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, 60 Series, CA | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/HTD Humid, 60 Series, 30cm, AHP | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDxS Headbox, NA | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE Auto with SD Slot, US | FDA UDI | Class II | Active |
| DreamWear | 1137468 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube. w/Cell, CA | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced System One, 60 Series, DE | FDA UDI | Class II | Active |
| BiPAP A40 | INX3000T19 | FDA UDI | Class II | Active |
| Nebulizing Elbow | EE Nebulizing Elbow Kit, KR | FDA UDI | Class II | Unknown |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T ST30 AAM, ES | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.41 | FDA UDI | Class II | Active |
| Sensor | AIR FLOW SENSOR 1 CH.ADULT CANN.STYLE | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/HT Humid System One 60 Series, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Wi-Fi Accessory, US with oximetry | FDA UDI | Class I | Active |
| EncorePro 2, Software | 2.22 | FDA UDI | Class II | Active |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem with Oximetry, EU | FDA UDI | Class I | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 60 Series, FR | 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