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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 68 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Care Cycle Connect Application | K161411 | FDA 510(k) | Class II | Active |
| Comfortlite Nasal Mask | K053352 | FDA 510(k) | Class II | Active |
| Oasis Humidifier | K964653 | FDA 510(k) | Class II | Active |
| Respironics Rescue Dome | K833328 | FDA 510(k) | Class I | Active |
| Respironics Bageasy Encor Adult Semi-Reusable | K934699 | FDA 510(k) | Class II | Active |
| Respironics Reusable Heated Tubing | K140424 | FDA 510(k) | Class II | Active |
| Respironics Venteasy | K842693 | FDA 510(k) | Class II | Active |
| Reusable Contour Ii Nasal Mask | K991648 | FDA 510(k) | Class II | Active |
| M-Series Pro Cpap Sytem | K052110 | FDA 510(k) | Class II | Active |
| Respironics Custom I Oral Appliance | K033822 | FDA 510(k) | Class II | Active |
| Simple T Nasal Mask | K121631 | FDA 510(k) | Class II | Active |
| Bipap Avaps Ventilatory Support System | K092818 | FDA 510(k) | Class II | Active |
| Remstar Se | K122769 | FDA 510(k) | Class II | Active |
| Exercise Respiratory Gas Analyzer | K770123 | FDA 510(k) | Class II | Active |
| Aria Lx Cpap System | K993307 | FDA 510(k) | Class II | Active |
| Stardust | K973920 | FDA 510(k) | Class II | Active |
| Respironics Ptl Reviveeasy | K863172 | FDA 510(k) | Class II | Active |
| Respironics Simplyclear Device | K122111 | FDA 510(k) | Class II | Active |
| Bipap Harmony S/T, Model 1001445 | K984407 | FDA 510(k) | Class II | Active |
| Trilogy Series Ventilator With Oximetry | K111610 | FDA 510(k) | Class II | Active |
| Bipap Plus M-Series Bi-Level System | K061034 | FDA 510(k) | Class II | Active |
| Actical | K060919 | FDA 510(k) | Class II | Active |
| Respironics' Remstar(tm) Sleepeasy | K900113 | FDA 510(k) | Class II | Active |
| Monitor, Heartwatch Heart Rate | K770038 | FDA 510(k) | Class II | Active |
| Bronchoscopy Elbow | K132168 | FDA 510(k) | Class II | Active |
| DreamStation 2 System, DreamStation 2 Advanced System | K200480 | FDA 510(k) | Class II | Active |
| Respironics Bilichek Non-Invasive-100-0800-20; Bilirubin Analyzer | K010052 | FDA 510(k) | Class I | Active |
| Browser (event Software) Model # 4500e | K982550 | FDA 510(k) | Class II | Active |
| Respironic's Infant Secureeasy | K882079 | FDA 510(k) | Class I | Active |
| Roll Stand mounting plate BiPAP A-series | 1115268 | EUDAMED | Class I | Active |
| BiPAP Auto BiFlex System One 60 Series INT | IN761S | EUDAMEDFDA UDI | Class IIa | Active |
| Trilogy Evo Detachable Battery Pack | 1127889 | EUDAMEDFDA UDI | Class I | Active |
| AW CT Koneksa Pkg LPS16677 Site | 1147350 | EUDAMED | Class IIa | Active |
| DreamStation Wi-Fi Accessory, EU | 300723W | EUDAMEDFDA UDI | Class I | Active |
| REMstar SE with HUMIDIFIER, with SD Slot, INTL | IN221HS | EUDAMEDFDA UDI | Class IIa | Active |
| Philips NightBalance Mobile App, iOS | 1142206 | EUDAMED | Class IIa | Active |
| Li Ion Battery, PAP Device Cable | 1121736 | EUDAMED | Class I | Active |
| Dorma 400, DE- RENTAL | RDEV402 | EUDAMED | Class IIa | Active |
| Trilogy Evo, Nordics | ND2110X15B | EUDAMEDFDA UDI | Class IIb | Active |
| Cable, 12/24V Battery, With Terminals | 1127401 | EUDAMED | Class I | Active |
| Nuance Pro Gel Pillows Mask W/Hgr, Intl | 1105168 | EUDAMEDFDA UDI | Class IIa | Active |
| DreamStation Wi-Fi Accessory, EU | 100723W | EUDAMEDFDA UDI | Class I | Active |
| AW CT Insmed INS 415 Pkg Site | 1149147 | EUDAMED | Class IIa | Active |
| Philips NightBalance, Refurbishment Kit, Canada | RPL2US01CA | EUDAMED | Class IIa | Active |
| AW CT Bayer 20887 Scorer | 1148542 | EUDAMED | Class IIa | Active |
| AW CT Janssen 42756493BLC3001 Pkg Scorer | 1139805 | EUDAMED | Class IIa | Active |
| Trilogy Evo O2, France | FR2100X14B | EUDAMED | Class IIb | Active |
| CoughAssist 70 Series Circuit, Adult Large, 9ft | 1098408 | EUDAMEDFDA UDI | Class IIa | Active |
| LiteTouch | 1083784 | EUDAMEDFDA UDI | Class I | Active |
| DreamStation Micro-Flex PR12 Tube Starter Pack | 1128071 | EUDAMEDFDA UDI | Class IIa | 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