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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 62 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamWisp | DreamWisp Mask, Large, Med Connector w/Headgear, CEE | FDA UDI | Class II | Active |
| Hl7 | Software, HL7 Forwarding Service - 3 | FDA UDI | Class I | Active |
| Performatrak | PERFORMATRAK FULL FACE MASK W CAPSTRAP,JPN, MEDIUM | FDA UDI | Class II | Unknown |
| Trilogy 200 | Trilogy200 Ventilator, Korea (Philips) | FDA UDI | Class II | Unknown |
| DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/WiFi, US | FDA UDI | Class II | Active |
| Wisp | Wisp Nasal Mask with Headgear, Fabric Frame, USA | FDA UDI | Class II | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME and Headgear, Large, US | FDA UDI | Class II | Active |
| Broadband | Broadband/Oximetry Accessory, Intl | FDA UDI | Class I | Active |
| Remote Alarm | Remote Alarm International | FDA UDI | Class II | Active |
| Performatrak | Performatrak Mask with SE and Headgr, Small, Disp, INTL | FDA UDI | Class II | Active |
| Therapy Mask 3100 | Medium Wide, Therapy Mask 3100 Silicone | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Fabric Frame, without headgear, US | FDA UDI | Class II | Active |
| SimplyGo Mini | SimplyGo Mini with Extended Battery, SA | FDA UDI | Class II | Unknown |
| Performatrak | PerformaTrak Full Mask, Large, with CapStrap, Single Use | FDA UDI | Class II | Active |
| Nuance Pro | Nuance Pro Gel Pillows Mask and Headgear, No Cushion, INTL | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| Sleepware | 3.8 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 2 with 4 PT Headgear, Medium, SU | FDA UDI | Class II | Unknown |
| Wisp | 00 | FDA UDI | Class II | Active |
| EverFlo | EverFlo w/Oxygen Percentage Indicator, 230V, IT, CL | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, JPN, Child Med, Leak 3, Single Use | FDA UDI | Class II | Unknown |
| Nebulizing Elbow | EE Nebulizing Elbow Kit, US | FDA UDI | Class II | Active |
| DreamStation Auto BiPAP wHumCell, LA | 00 | FDA UDI | Class II | Active |
| Care Orchestrator | 1.28 | FDA UDI | Class II | Active |
| DreamStation Go | LAG502S15 | FDA UDI | Class II | Active |
| PerformaTrak | Standard Elbow Starter Kit, PerformaTrak plus CapStrap | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, SMALL | FDA UDI | Class II | Active |
| ALICE PDX Assembly, BR | BRAZIL | FDA UDI | Class II | Active |
| Sensor | Snore Microphone, 249 | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Small, Leak 3, Single Use | FDA UDI | Class II | Active |
| Sleepware | Sleepware G3 Software, Multi-Lingual - 3 | FDA UDI | Class II | Active |
| DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humidifier w/Cell, US | FDA UDI | Class II | Active |
| DreamMapper | 2.17 | FDA UDI | Class II | Active |
| Comfortfull 2 | COMFORTFULL 2 Mask with Headgear, Reusable, Small, China | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation CPAP Pro w/Humid w/H Tube. w/WiFi, CA | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, CA | FDA UDI | Class II | Active |
| Amara View | Amara View Mask with Headgear, Small, US | FDA UDI | Class II | Active |
| DreamWear | 1137387 | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto BiPAP, GB | FDA UDI | Class II | Active |
| Therapy Interface Tubing kit | 1082650 | FDA UDI | Class II | Active |
| Alice 6 | Alice 6 LDE Headbox, INTL | FDA UDI | Class II | Active |
| Invasive Circuit | 00 | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/WiFi, AHP | FDA UDI | Class II | Unknown |
| OmniLab Direct | OmniLab Direct Software - 2 | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Clear Frame, with headgear, Petite, US | FDA UDI | Class II | Active |
| BiPAP A40 | NDX3000T19 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP Pro w/Humid w/H Tube, Latin America | FDA UDI | Class II | Active |
| DreamStation | DreamStation S/T 30 w/Heated Humidifier, EE | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, INTL, Child Large, SE, ASM | FDA UDI | Class II | Active |
| OmniLab Advanced Plus | OmniLab Advanced Plus, INTL | 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