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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 14 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP System One 60 Series | BiPAP Pro BiFlex, BR | FDA UDI | Class II | Unknown |
| BiPAP AVAPS. | BiPAP AVAPS C Series Core Pack w/Heated Tube, 30cm, US | FDA UDI | Class II | Unknown |
| PerforMax | PerforMax Mask with SE, Single Patient Use, INTL, Small | FDA UDI | Class II | Active |
| EverFlo | EVERFLO w/O2 Percentage Indicator, 120V US, BR | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask w/ Headgear, Large, Disposable, INTL | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Medium, w/Medium Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| Phonix System One 60 Series | PHONIX 3i, H&L | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Wisp | 1137368 | FDA UDI | Class II | Active |
| PerforMax | PerformaxMask, EE, Leak2, SE, 4 PT Hdgr, MPU, INTL, Large | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS30, US | FDA UDI | Class II | Active |
| BiPAP A40 | EEX3100S19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP S/T 25, IT | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, IT | FDA UDI | Class II | Unknown |
| System One | System One Heated Tube Humidifier, PT | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, INT, MEDIUM | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Unknown |
| DreamMapper Mobile App Android (DMM) | 2.13 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV, TR | FDA UDI | Class II | Active |
| Trilogy Evo | CA2100X12B | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto, FR | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Heated Humidifier, Core Pack, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/Heated Tube, CN | FDA UDI | Class II | Unknown |
| Af541 | AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Large | FDA UDI | Class II | Active |
| Actiwatch Spectrum Plus | Actiwatch Spectrum Plus, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation AVAPS 30 with Heated Humidifier, AAM ND | FDA UDI | Class II | Active |
| DreamMapper App iOS (APAC) | 2.9 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Hum, 30cm, 60 Series, LA | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.40 | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (DMM) | 2.10 | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus with Humidifier, JP | FDA UDI | Class II | Unknown |
| Performatrak | Performatrak Mask with Headgear, Disposable, LARGE, Korea | FDA UDI | Class II | Unknown |
| EncorePro | 2.20 | FDA UDI | Class II | Active |
| Sensor | GRASS Piezo Sensor P | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.5 | FDA UDI | Class I | Active |
| REMstar SE | 00 | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, L, S-M-L Connector w/Hdgr, JN | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex, w/HT Humid System One 60 Series LA | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with 2 Standard Batteries, US | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Cell, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, TR | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP AutoBiFlex w/HTD Humid, BTooth, Sys One 60Srs, AHP | FDA UDI | Class II | Active |
| DreamWear Full | 00 | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Full Mask, Large, w/SE and CapStrap, SU | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, USA | FDA UDI | Class II | Active |
| BiPAP AVAPS | 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