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Sign in to claim this brandRespironics, Inc.
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 6 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trilogy100 Ventilator, Japan-Rental | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR | FDA UDI | Class II | Active |
| PerformaTrak | Standard Elbow Starter Kit, Oro-Nasal Package | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | BiPAP Hybrid A30 Ventilator with Humidifier, Japan | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro w/Cell, US | FDA UDI | Class II | Active |
| System One | System One Heated Humidifier, Finland | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask, FitPack | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class II | Active |
| Easylife | EasyLife Mask w/Headgear, Medium, Japan | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6 LDxN Headbox, Brazil | FDA UDI | Class II | Unknown |
| PerformaTrak | PERFORMATRAK FULL FACE MASK WITH CAP STRAP, LARGE | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+, System One 60 Series, DE | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro with Humidifier, AHP | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Auto A-Flex w/ Humid, System One 60 SRs, CN | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, ES | FDA UDI | Class II | Unknown |
| PerformaTrak | CapStrap with FEP Procedure Pack, Medium, SA | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/Humid, 60 Srs, 30cm, AHP | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Pro Bi-Flex w/ Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| Pro-Flow | PRO-FLOW- PLUS NASALORAL CANNULA ADULT 1.1M | FDA UDI | Class II | Active |
| A Series | A Series System One Heated Humidifier, JP | FDA UDI | Class II | Unknown |
| Alice 6 | Alice 6, Base Station, LDx, INTL | FDA UDI | Class II | Active |
| DreamStation | PWX401S15 | FDA UDI | Class II | Active |
| PerforMax | Performax Mask, Single Use w/SE, Small | FDA UDI | Class II | Active |
| DreamMapper iOS China Instance | 2.13 | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/o Headgr, Medium, USA | FDA UDI | Class II | Active |
| Amara | Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,INTL | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Heated Humidifier, CE | FDA UDI | Class II | Active |
| Af531 | AF531Mask EE,Leak1,Circuit, Neb Elbow,Capstrap, SU, M, US | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro, AU | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, 60 Series, AU | FDA UDI | Class II | Active |
| Af541 | AF541 Mask with SE, Under the Nose, Capstrap, Size A, JP | FDA UDI | Class II | Unknown |
| PerforMax | Performax Mask w/SE, 4 PT Headgr, MPU, INTL, Large | FDA UDI | Class II | Active |
| Pro-Tech | CANNULA | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| EverFlo | EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, AU | FDA UDI | Class II | Unknown |
| DreamMapper Web (DM) | 2.18 | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 30cm, 60 Series, US | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation AVAPS 25, EU | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP, KR | FDA UDI | Class II | Unknown |
| DreamWear Full | DreamWear Full Mask Medium, w/Medium Frame w/Headgear, Global | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, w/Capstrap, SIZE B | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced, 30cm, 60 Series, CA | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus C-Flex, w/H Tube Humid, Sys One 60 Series, LA | FDA UDI | Class II | Unknown |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Sensor | PRO-FLOW MULTIPURPOSE NASAL CANNULA, PEDIATRIC, REGULAR | FDA UDI | Class II | Active |
| Alice 6 | Alice 6, Base Station, LDE, NA | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, SE, Under Nose, 4 PT HEADGEAR, SIZE C | FDA UDI | Class II | Active |
| A Series, Sys One, Heater Hum | 00 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.8 | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with SD Slot, CA | 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