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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 65 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cable, Remote Alram, RJ9, 50ft | 1114933 | EUDAMED | Class I | Active |
| AW CT Janssen 42847922MDD3001 Site | 1147948 | EUDAMED | Class IIa | Active |
| AW CT Insmed INS 415 Pkg Scorer | 1149146 | EUDAMED | Class IIa | Active |
| BiPAP A30, International-Rental | R1111143 | EUDAMED | Class IIb | Active |
| Alice NightOne System Intl, Wireless, Rental | R1114801 | EUDAMED | Class IIa | Active |
| Contour Deluxe Su W/Headgear, S, Int – 5 Pack | 1016697 | EUDAMED | Class IIa | Active |
| DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global | 1125022 | EUDAMEDFDA UDI | Class IIa | Active |
| Garbin Ventilator, DE | 1040001 | EUDAMEDFDA UDI | Class IIb | Active |
| Novartis Software PkgScorer | 1132329 | EUDAMED | Class IIa | Active |
| Magneto Nasal Mask | K210386 | FDA 510(k) | Class II | Active |
| Respironics Protecteasy | K863171 | FDA 510(k) | Class I | Active |
| Virtuoso Lx Smart Cpap System | K993433 | FDA 510(k) | Class II | Active |
| Stick-On Disposable Nasal Mask, Model 312174, 1001964 | K990574 | FDA 510(k) | Class II | Active |
| Care Orchestrator Essence | K183226 | FDA 510(k) | Class II | Active |
| Image3 Se Disposable Full Face Mask | K023135 | FDA 510(k) | Class II | Active |
| Performax Pediatric Se Total Face Mask | K120639 | FDA 510(k) | Class II | Active |
| Bipap Pro 2 Bi-Level System With Bi-Flex | K043607 | FDA 510(k) | Class II | Active |
| Trilogy 200 Ventilator | K093416 | FDA 510(k) | Class II | Active |
| Bipap Autosv | K063540 | FDA 510(k) | Class II | Active |
| Remstar Auto A-Flex Ht | K113068 | FDA 510(k) | Class II | Active |
| Bipap Synchrony Hc | K992530 | FDA 510(k) | Class II | Active |
| Monarch Ii Mini Mask | K992336 | FDA 510(k) | Class II | Active |
| Quartet Clinical System | K963761 | FDA 510(k) | Class II | Active |
| Smartmonitor 2 Professional Series (ps) | K032403 | FDA 510(k) | Class II | Active |
| Sidestream Plus | K062689 | FDA 510(k) | Class II | Active |
| Trilogy 202 Ventilator | K093905 | FDA 510(k) | Class II | Active |
| Remstar Pro M-Series Cpap & Heated Humidifier System | K072996 | FDA 510(k) | Class II | Active |
| Respironics Sleepeasy Cpap System | K091112 | FDA 510(k) | Class II | Active |
| Plix | K050414 | FDA 510(k) | Class II | Active |
| Solo Cpap System | K961626 | FDA 510(k) | Class II | Active |
| Humidifier | K945782 | FDA 510(k) | Class II | Active |
| Respironics Golox | K072723 | FDA 510(k) | Class II | Active |
| Ventilator, Non-continuous (Respirator) | K201439 | FDA 510(k) | Class II | Active |
| Remstar Se | K130077 | FDA 510(k)FDA UDI | Class II | Active |
| Aria Cpap System | K953341 | FDA 510(k) | Class II | Active |
| Respironics Bipap Pressure Alarm (bipap P.a.) | K902276 | FDA 510(k) | Class II | Active |
| Respironics Sanders Bipapeasy | K871523 | FDA 510(k) | Class II | Active |
| Respironics Sealeasy Ii | K890795 | FDA 510(k) | Class I | Active |
| Bipap Duet Lx Bi-Level System | K000994 | FDA 510(k) | Class II | Active |
| Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | K961915 | FDA 510(k) | Class II | Active |
| Remstar Wtih Ramp And Remote Modification | K920699 | FDA 510(k) | Class II | Active |
| H2 Heated Humidifier | K030090 | FDA 510(k) | Class II | Active |
| Cricket 2000 Recording Pulse Oximeter | K972829 | FDA 510(k) | Class II | Active |
| Comfortlite Nasal Mask | K082558 | FDA 510(k) | Class II | Active |
| Simple T Youth Nasal Mask | K140268 | FDA 510(k) | Class II | Active |
| Respironics Pr Valve | K833327 | FDA 510(k) | Class II | Active |
| Respironics Heated Humidifier | K012633 | FDA 510(k) | Class II | Active |
| Rescue Valve | K833748 | FDA 510(k) | Class II | Active |
| Hayek Oscillator(tm) | K924341 | FDA 510(k) | Class II | Active |
| C2 Nasal Mask | K033759 | FDA 510(k) | 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