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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 3 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Af531 | AF531 Mask w/SE, with 4 point Headgear, Medium, SU | FDA UDI | Class II | Unknown |
| Sensor | Airflow Sensor Thermistor, Oral, 249 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, w/H Tube Humid, 60 Series, CA | FDA UDI | Class II | Active |
| EverFlo | EverFlo, w/O2 Percent Ind, CEE 7/7, 230V, UltraFill, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C Flex, w/Humid, System One 60 Series, IT | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C-Flex, w/Humid, Sys One 60 Series, LA | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP AVAPS30 AAM w/Humidifier, CA | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, 22 mm (M), Small, US | FDA UDI | Class I | Active |
| REMstar System One 60 Series | REMstar Plus, CA | FDA UDI | Class II | Active |
| Sensor | THERMISTOR AIRFLOW SENSR,1 CH, PED RESP | FDA UDI | Class II | Active |
| DreamStation | DreamStation, BiPAP AutoSV with Humidifier, IT | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL FACE MASK W CAPSTRAP,INT, SMALL | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask Small, Medium Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak1 with CapStrap, Large, China | FDA UDI | Class II | Active |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| Pn841 | PN841 Mask, INTL, Child Large, Leak 3, Single Use | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto P-Flex, w/H Tube Humid, Sys One 60 Series, FR | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 TR | FDA UDI | Class II | Active |
| DreamStation | Cellular Modem, US | FDA UDI | Class I | Unknown |
| DreamWear | 1138389 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, System One 60 Series, ES | FDA UDI | Class II | Active |
| PerforMax | PerforMax Mask w/EE and SE, Leak2, 4 PT Headgr, MPU, XL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, TR | FDA UDI | Class II | Active |
| REMstarSystem One 60 Series | REMstar Pro C-Flex+, w/HT Humid System One 60 Series CN | FDA UDI | Class II | Unknown |
| Pro-Flow | PRO-FLOW MULTIPURPOSE NASAL CANNULA, ADULT, SINGLE | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Med, SU | FDA UDI | Class II | Active |
| BiPAP A40 | PPX3110S10 | FDA UDI | Class II | Active |
| Trilogy | Trilogy200 Ventilator, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, EE | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, BR | FDA UDI | Class II | Unknown |
| DreamWear | DreamWear Under Nose Mask, Fitpack w/Headgear, USA | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL FACE MASK W CAPSTRAP,INT, LARGE | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium, w/ Large Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, AHP | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/WiFi, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro with Humidifier, GB | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, US | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Cellular Modem with Oximetry, US | FDA UDI | Class I | Active |
| SimplyGo Mini | SimplyGo Mini with Standard Battery, US | FDA UDI | Class II | Active |
| Af531 | 00 | FDA UDI | Class II | Unknown |
| Amara | AMARA MASK w/SE, with RS FRAME, RS Headgear, Petite, CN | FDA UDI | Class II | Unknown |
| Af531 | AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro with Humidifier, US | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| DreamStation | DreamStation Auto CPAP wHumid, ND | 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