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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 17 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamStation | DreamStation BiPAP autoSV, ND | FDA UDI | Class II | Active |
| DreamMapper Mobile App Android (APAC) | 2.11 | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Fabric Frame, with Headgear, MW, Japan | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Pro C-Flex+, System One 60 Series, FI | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, EU | FDA UDI | Class II | Active |
| Ac611 | AC611 High Flow Nasal Cannula, 22mm (M), Large, NA | FDA UDI | Class I | Active |
| Airflow Sensor | Airflow Sensor Thermistor, Neonatal 249 | FDA UDI | Class II | Active |
| DreamStation | DreamStation BiPAP AutoSV, EU | FDA UDI | Class II | Active |
| zRIP | zRIP DuraBelt Kit, Adult, A5 | FDA UDI | Class II | Active |
| BiPAP A40 | BiPAP A40 Ventilator with Humidifier, AU | FDA UDI | Class II | Unknown |
| Dorma 200 | 207V | FDA UDI | Class II | Active |
| Care Orchestrator | 1.12 | FDA UDI | Class II | Active |
| Alice PDx | Alice PDx Core System without Sensors, JP | FDA UDI | Class II | Unknown |
| DreamStation | DreamStation BiPAP Pro with Humidifier, with Cell, AHP | FDA UDI | Class II | Unknown |
| PerforMax | Performax Mask, Single Use with EE, Leak 2 - Single, Large | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Plus C-Flex, with Humidifier, 60 Series, INTL | FDA UDI | Class II | Unknown |
| Total Face Mask | 00 | FDA UDI | Class II | Active |
| ALICE PDX Assembly, DOM | DOMESTIC | FDA UDI | Class II | Active |
| zRIP | Alice 6 zRIP Pediatric Kit | FDA UDI | Class II | Active |
| ezRIP | ezRIP, thorax, 249, 84 inch | FDA UDI | Class II | Active |
| DreamStation | 00 | FDA UDI | Class I | Active |
| DreamStation | DreamStation BiPAP autoSV w/Humidifier, US | FDA UDI | Class II | Active |
| Wisp | Wisp Mask, Fabric Frame, without headgear, Small/Medium, US | FDA UDI | Class II | Active |
| DreamStation | DreamStation Auto CPAP with Humidifier, BL | FDA UDI | Class II | Active |
| Pico | 00 | FDA UDI | Class II | Active |
| Dorma 400 | Dorma 400, DE | FDA UDI | Class II | Active |
| DreamMapper | 2.7 | FDA UDI | Class II | Active |
| Af531 | AF531 EE Leak1 NE 4PT Headgear, Single Use,Small, US | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with SD Slot, AH | FDA UDI | Class II | Active |
| DreamStation | DreamStation CPAP w/Humidifier, w/Cell, AHP | FDA UDI | Class II | Unknown |
| BiPAP System One 60 Series | BiPAP Auto BiFlex w/Hum Sys One 60 Series, ND | FDA UDI | Class II | Active |
| Trilogy 100 | RTO Trilogy 100 Ventilator, U.S.A | FDA UDI | Class II | Active |
| DreamWisp | DreamWisp Mask, P, S-M-L Connector w/HDGR, JN | FDA UDI | Class II | Unknown |
| REMstar System One 60 Series | REMstar Plus CFlex, Sys One, 60 Series, ND | FDA UDI | Class II | Active |
| DreamStation | DreamStation Heated Humidifier, EE | FDA UDI | Class II | Active |
| Sensor | SPI BODY SENSOR | FDA UDI | Class II | Active |
| DreamMapper | 2.20 | FDA UDI | Class II | Active |
| Circuit Tubing | Performance Tubing, 6 ft. (1.83m), White, CN | FDA UDI | Class I | Active |
| BiPAP System One 60 Series | BiPAP Auto BiFlex with Humidifier System One 60 Series,ES | FDA UDI | Class II | Active |
| BiPAP A40 | INX3100T19 | EUDAMEDFDA UDI | Class II | Active |
| Sleepware | Sleepware G3 Software, English - 3 | FDA UDI | Class II | Active |
| Af541 | 00 | FDA UDI | Class II | Active |
| Amara | AMARA MASK WITH RS FRAME AND RS HEADGEAR, PETITE, INTL | FDA UDI | Class II | Active |
| Amara View | 00 | FDA UDI | Class II | Active |
| Amara | AMARA STARTER KIT, Petite | FDA UDI | Class II | Active |
| Wisp | 1118060 | FDA UDI | Class II | Active |
| REMstar System One 60 Series | REMstar Pro, CN | FDA UDI | Class II | Unknown |
| DreamWear | 1137470 | FDA UDI | Class II | Active |
| REMstar SE | REMstar SE with Heated Tube, with SD Slot, US | FDA UDI | Class II | Unknown |
| PLV Circuit Accessories | 00 | 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