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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 43 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sensor | Airflow Thermistor, .10k Adult | FDA UDI | Class II | Active |
| DreamWear | DreamWear Full Mask, M, with Small-Medium Frame, KR | FDA UDI | Class II | Unknown |
| BiPAP A40 | BiPAP A40 Pro, AR | FDA UDI | Class II | Active |
| BiPAP ST | 00 | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humid w/Heated Tube, US | FDA UDI | Class II | Active |
| DreamMapper App iOS | 2.10 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, Latin America | FDA UDI | Class II | Active |
| UltraFill | ULTRAFILL,230V, Australia | FDA UDI | Class II | Active |
| DreamMapper | DreamMapper iOS, China Instance - 2 | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 25 with Heated Humidifier, DE | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/Humid System One 60 Series US | FDA UDI | Class II | Active |
| BiPAP A30 | BiPAP A30 Ventilator w/H Tube Humid, CA | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, US | FDA UDI | Class II | Active |
| Trilogy 100 | Trilogy 100 Ventilator, Bluetooth, Australia | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, EU | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, PT | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne System, NA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| CoughAssist | 00 | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series Core Pack w/Heated Tube, 30cm, CN | FDA UDI | Class II | Unknown |
| Nebulizing Elbow | Entrainment Elbow Nebulizing Elbow Kit | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Small, SE, Single Use | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30CM, ES | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex w/ Humidifier, BlueTooth, 60 Series, CA | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, System One 60 Series, PT | FDA UDI | Class II | Active |
| Performax | Performax Mask with EE, Leak 2, Single Use, XSmall, China | FDA UDI | Class II | Unknown |
| PerforMax | PerforMax with FEP Procedure Pack, Small | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Trilogy | Trilogy 100 w/Bluetooth, International | FDA UDI | Class II | Active |
| Nuance | NUANCE GEL MASK and HEADGEAR, NO CUSHION, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, AR | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T30 AAM no Bluetooth, INTL | FDA UDI | Class II | Active |
| DreamMapper App iOS (APAC) | 2.13 | FDA UDI | Class II | Active |
| PerforMax | PerforMax w/Filtered Exhal Port Procedure Pack, L | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Pro BiFlex, System One 60 Series, AHP | FDA UDI | Class II | Active |
| Af531 | AF531 Mask, SE with CapStrap, Large, Single Use | FDA UDI | Class II | Unknown |
| Exhalation Port Circuit | Filtered Exhalation Port Circuit without Filters | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Small, SU | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Petite, Fabric Frame, with Headgear, INTL | FDA UDI | Class II | Active |
| Broadband | Broadband Modem | FDA UDI | Class I | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/Headgear, Lab, Petite, USA | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, System One 60 Series, AU | 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