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L, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1146450APModel DreamWear Silicone Pillows Mask
Identity
- Trade Name
- L, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific EUDAMEDDreamWear FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Large, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific FDA UDI
- Model / Reference
- DreamWear Silicone Pillows Mask EUDAMED1146450AP EUDAMEDDreamWear Silicone Pillows,Large, Large Frame with Headgear, Asian Pacific FDA UDI
- Description
- Large, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific FDA UDI
Identifiers
- Catalog Number
- 1146450AP FDA UDI
- Primary DI / UDI-DI
- 00606959062122 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959062122 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rebreathing oxygen face mask
L, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific by Respironics Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210844 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00606959062122 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 91bc05b3-f4b9-48e0-9347-e2e6a3d7037f 61 fields · synced Jul 21, 2026
- FDA UDI d48fdb4a-7141-4fd2-82a6-582a8d4ee82d 36 fields · synced May 22, 2026
- FDA 510(k) K210844 1 fields · synced May 25, 2026