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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 61 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DreamWear Full | DreamWear Full Mask Small, w/Small Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| Af531 | AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Med, SU | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| DreamWisp | 00 | FDA UDI | Class II | Active |
| Pico | Pico Traditional Nasal Mask with Headgear, XLarge, INTL | FDA UDI | Class II | Active |
| Airflow Sensor | Airflow Sensor Thermistor Pediatrics, 249 | FDA UDI | Class II | Active |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| DreamMapper | 2.23 | FDA UDI | Class II | Active |
| BiPAP S/T C-Series | BiPAP S/T C Series, 30cm, SE | FDA UDI | Class II | Active |
| Af541 | AF541 Mask, EE, Leak 1 with Capstrap, Medium | FDA UDI | Class II | Active |
| DreamMapper | 2.6 | FDA UDI | Class I | Active |
| Amara Gel | AMARA GEL MASK with RS FRAME and Headgear, Medium, JP | FDA UDI | Class II | Unknown |
| Trueblue | 00 | FDA UDI | Class II | Unknown |
| Broadband | Broadband/Oximetry Accessory, US | FDA UDI | Class I | Unknown |
| Alice 6 | Alice 6 Base Station, LDx with Masimo, NA | FDA UDI | Class II | Active |
| DreamMapper App iOS | 2.9 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1 with 4 PT Headgear, Large, Single Use | FDA UDI | Class II | Unknown |
| Somnolyzer | Somnolyzer Software Service 24x7 - 2 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto with Bluetooth, Nordics | FDA UDI | Class II | Active |
| Nebulizing Elbow | EE Nebulizing Elbow Kit, Single - United States | FDA UDI | Class II | Active |
| Amara | 00 | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Full Mask, Medium, w/SE and CapStrap, SU | FDA UDI | Class II | Active |
| ezRIP | ezRIP, Abdomen, 249, 20 inch | FDA UDI | Class II | Active |
| Wisp | Wisp Nasal Mask with Headgear, Fabric Frame, Large, Japan | FDA UDI | Class II | Unknown |
| DreamStation Go | DreamStation Go Auto, with Bluetooth, Flagship, Nordics | FDA UDI | Class II | Active |
| BiPAP V30 Auto | 00 | FDA UDI | Class II | Active |
| DreamMapper | 2.24 | FDA UDI | Class II | Active |
| PerformaTrak | PerformaTrak with FEP Procedure Pack, Large, SA | FDA UDI | Class II | Active |
| Pn841 | PN841 Mask, JPN, Child Small, SE, Single Use | FDA UDI | Class II | Unknown |
| Wisp | Wisp Mask, Clear Frame, without Headgear, XL, US | FDA UDI | Class II | Active |
| Af531 | AF531 Mask w/SE, w/4 PT Headgear, SU, Small, CN | FDA UDI | Class II | Unknown |
| DreamStation Go | CAG400H12 | FDA UDI | Class II | Active |
| Simplygo | FR1113604 | FDA UDI | Class II | Active |
| DreamStation Go | DreamStation Go Auto CPAP with Bluetooth, FS Store, EU | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size A, JP | FDA UDI | Class II | Unknown |
| EncoreAnywhere | 2.32 | FDA UDI | Class II | Active |
| zRIP DuraBelt | ZRIP DURABELT | FDA UDI | Class II | Active |
| DreamStation Go | DSG500H11 | FDA UDI | Class II | Active |
| DreamWear Full | DreamWear Full Mask Lareg, w/Small Frame w/o Headgear, Global | FDA UDI | Class II | Active |
| Care Orchestrator | Care Orchestrator, Clinical data collection software - 1 | FDA UDI | Class II | Active |
| Af531 | AF531 Mask EE, Leak 1, with 4 PT Headgear, Medium, China | FDA UDI | Class II | Unknown |
| DreamStation Go | DSGHCP | FDA UDI | Class II | Active |
| Performatrak | PerformaTrak Full Mask, Small, w/SE w/CapStrap, SU | FDA UDI | Class II | Active |
| Care Orchestrator | 1.27 | FDA UDI | Class II | Active |
| DreamMapper Web (APAC) | 2.11 | FDA UDI | Class II | Active |
| DreamMapper Android China Instance v 2.11 | 2.11 | FDA UDI | Class II | Active |
| Af541 | AF541 Mask EE, Leak 2, Under Nose, 4-PT HEADGR, SIZE A | FDA UDI | Class II | Active |
| PerformaTrak | PerformaTrak SE Mask w 4 Point Headgear, SU, Large, CN | FDA UDI | Class II | Unknown |
| Dreamstation BiPAP AVAPS | DreamStation BiPAP S/T, AVAPS, Private label, Postponement | FDA UDI | Class II | Active |
| Amara | AMARA STARTER KIT, Small | 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