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S DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1125015
Identity
- Trade Name
- S DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global EUDAMEDDreamWear FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- DreamWear Gel Pillows EUDAMEDDreamWear Gel Pillows Mask, Small, with Medium Frame, with Headgear, Global , FDA UDI
- Model / Reference
- 1125015 EUDAMEDDreamWear Gel Pillows Mask, S, Medium Frame w/Hgr, Global FDA UDI
- Description
- DreamWear Gel Pillows Mask, Small, with Medium Frame, with Headgear, Global , FDA UDI
Identifiers
- Catalog Number
- 1125015 FDA UDI
- Primary DI / UDI-DI
- 00606959026896 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959026896 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
S DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Rebreathing oxygen face mask.
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- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959026896 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 25823f77-316e-423f-a16c-5b9eae7990a1 61 fields · synced Oct 6, 2026
- FDA UDI 9047ba30-c1cc-444f-96bd-ab28ea5c36f8 36 fields · synced May 30, 2026
- EUDAMED dd8156dc-d814-41bc-8ba4-c9ef3941deb0 61 fields · synced Jul 10, 2026