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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 15 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EverFlo | EverFlo, w/O2 Percent Indic, CEE 7/7, 230V, UltraFill, IKK | FDA UDI | Class II | Unknown |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, PL | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, CA | FDA UDI | Class II | Active |
| Circuits | Disposable Adult Heated Active Circuit, NO | FDA UDI | Class II | Active |
| ComfortGel Blue | ComfortGel Blue Nasal Mask w/SE, w/Headgr, Medium, JP | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.32 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 Base Station, LDx, INTL | FDA UDI | Class II | Active |
| EncoreAnywhere | 2.34 | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, GB | FDA UDI | Class II | Active |
| Alice 6 | LDE | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak SE Mask w/Headgear, Disp, Small, USA | FDA UDI | Class II | Active |
| BiPAP A40 | ITX3100H21 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP w/Humid w/H Tube, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro, TR | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Small-Medium, Fabric Frame, with Headgear, INTL | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Mask, Large, Reusable Pack, INTL | FDA UDI | Class II | Active |
| PerforMax | Performax Mask with EE, Leak 2, Single Use, XXSmall, KR | FDA UDI | Class II | Unknown |
| ComfortGel | 00 | FDA UDI | Class II | Active |
| Alice NightOne | Alice NightOne, Non-Wireless, Korea | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP S/T30 AAM w/Humidifier, DE | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Med, Leak 3, ASM | FDA UDI | Class II | Active |
| Contour Deluxe | Contour Deluxe Mask and Headgear, SPU, Medium Large, US | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro C-Flex+ w/ Humid, BTOOTH Sys One 60 Srs, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidifier, CA | FDA UDI | Class II | Active |
| BiPAP A40 | 00 | FDA UDI | Class II | Active |
| BiPAP AVAPS | BiPAP AVAPS C Series, 30cm, US | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.44 | FDA UDI | Class II | Active |
| Performax | Performax Mask with EE, Leak 2, Single Use, XXSmall, China | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation AVAPS 30 with Heated Humidifier, ND | FDA UDI | Class II | Active |
| Ac611 | 00 | FDA UDI | Class I | Active |
| Sensor | THERMIS AIR FLOW 1 CH ADULT EMBLETTA | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist 70 Series Circuit, Mouthpiece, 6ft | FDA UDI | Class II | Active |
| Nuance | Nuance Gel Pillows Mask, without headgear, Medium, USA | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Fabric Frame, with magnetic clips, US | FDA UDI | Class II | Active |
| Somnia System One 60 Series | SOMNIA 3i C-Flex+ System One 60 Series H&L | FDA UDI | Class II | Active |
| A Series | A Series, System One, Heated Humidifier, INTL | FDA UDI | Class II | Active |
| Pico | Pico Nasal Mask with Headgear, XLarge, China | FDA UDI | Class II | Unknown |
| PerforMax | PERFORMAX Mask with EE AND SE, LEAK 2, MPU, Xlarge | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Auto A-Flex, w/Humid, Sys One 60 Series, PT | FDA UDI | Class II | Active |
| DreamWear | DreamWear Under Nose Mask, S Frame w/Headgear, CN | FDA UDI | Class II | Unknown |
| Amara | 00 | FDA UDI | Class II | Active |
| CoughAssist | CoughAssist T70, US | FDA UDI | Class II | Active |
| DreamWear Gel Pillow | DreamWear Gel Pillows Mask, Med Frame w/Headgear, CN | FDA UDI | Class II | Unknown |
| BiPAP autoSV Advanced System One 60 Series | BiPAP autoSV Advanced with Humidifier, 60 Series, CA | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE with 4 point Headgear, Medium, USA | FDA UDI | Class II | Active |
| DreamStation | DreamStation AVAPS 25, IT | FDA UDI | Class II | Active |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/WiFi, CA | FDA UDI | Class II | Active |
| Care Orchestrator | 1.15 | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, FEP Connect, Large, INTL | FDA UDI | Class I | 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