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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 54 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BiPAP System One 60 Series | BiPAP Auto Bi-Flex w/HT Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| A Series | A Series, System One Humidifier, INTL | FDA UDI | Class II | Active |
| DreamMapper App iOS (APAC) | 2.10 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP with Humidifier, INTL | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM DE | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| DreamStation | 15MM Heated Tube | FDA UDI | Class II | Active |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Series, US | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation Auto BiPAP with Humidifier, KR | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced w/H Tube Humid, 60 Srs, 30cm, AU | FDA UDI | Class II | Unknown |
| Sensor | WIRESET, JUMPER, 1.5mm MALE | FDA UDI | Class II | Active |
| Circuit Tubing | Performance Tubing 6ft (1.83m) | FDA UDI | Class I | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation AVAPS30 w/Humidifier w/WiFi, US | FDA UDI | Class II | Active |
| Dorma 200 | Dorma 200, AH | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| Performatrak | PERFORMATRAK FULL SE W CAPSTRAP, INT, SMALL | FDA UDI | Class II | Active |
| Sensor | Sensor Snore Embletta | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Ac611 | 00 | FDA UDI | Class I | Active |
| Alice NightOne | Alice NightOne, DuraBelt, Adult Large | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, Small Child Small, SE, Single Use | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask SE, Medium, Reusable Pack, International | FDA UDI | Class II | Active |
| BiPAP System One 60 Series | BiPAP Auto Bi-Flex w/ Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP with Humidifier, KR | FDA UDI | Class II | Unknown |
| OmniLab Advanced Plus | OmniLab Advanced Plus, JP | FDA UDI | Class II | Unknown |
| Trilogy Evo | Trilogy Evo, O2, India | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/ Humid, w/Bluetooth, 60 Series, AHP | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask with Headgear, Disposable, MEDIUM, Korea | FDA UDI | Class II | Unknown |
| DreamWear | 00 | FDA UDI | Class II | Active |
| BiPAP A40 | FRX3000T14 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Med, SE, ASM | FDA UDI | Class II | Active |
| ComfortGel Blue Full | ComfortGel Blue Full Mask w/SE, Large, Japan | FDA UDI | Class II | Unknown |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, PT | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.2.0 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro, CA | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Medium Large, CN | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, AHP | FDA UDI | Class II | Active |
| Wisp Pediatric | Wisp Pediatric Fitpack with Headgear, EE, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP w/Humid w/H Tube, AU | FDA UDI | Class II | Active |
| DreamWear | 00 | FDA UDI | Class II | Active |
| Amara | AMARA MASK with RS FRAME and Headgear, Large, US | FDA UDI | Class II | Active |
| Af531 | A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU | FDA UDI | Class II | Active |
| Sensor | NK Piezo Effort 1 CH P Kit 1.5" | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C Flex, w/Humid, System One 60 Series, FI | FDA UDI | Class II | Active |
| Care Orchestrator | 1.21 | FDA UDI | Class II | Active |
| Wisp | 1118061 | 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