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DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1125022
Identity
- Trade Name
- DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global EUDAMEDDreamWear FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- DreamWear Gel Pillows EUDAMEDDreamWear Gel Pillows Mask, Medium, with Large Frame, with Headgear, Global FDA UDI
- Model / Reference
- 1125022 EUDAMEDDreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global FDA UDI
- Description
- DreamWear Gel Pillows Mask, Medium, with Large Frame, with Headgear, Global FDA UDI
Identifiers
- Catalog Number
- 1125022 FDA UDI
- Primary DI / UDI-DI
- 00606959026964 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959026964 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
DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Rebreathing oxygen face mask.
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- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- 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-00606959026964 | 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 9812bcce-1f32-434a-b39b-3e4f569aec9b 61 fields · synced Sep 18, 2026
- FDA UDI a5465f07-7c66-45b2-a17e-163e7bde40fa 36 fields · synced May 30, 2026
- EUDAMED c489b93e-c84a-43a9-8b21-e2cc0302ff48 61 fields · synced Sep 18, 2026