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DreamWear Under Nose Mask Large, Medium Frame w/Headgear, Global
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1116682
Identity
- Trade Name
- DreamWear Under Nose Mask Large, Medium Frame w/Headgear, Global EUDAMEDDreamWear FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- DreamWear Under the Nose EUDAMEDDreamWear Under the Nose Nasal Mask, Large, with Medium Frame, with Headgear, Global FDA UDI
- Model / Reference
- 1116682 EUDAMEDDreamWear Under Nose Mask, L, M Frame w/Headgr, Global FDA UDI
- Description
- DreamWear Under the Nose Nasal Mask, Large, with Medium Frame, with Headgear, Global FDA UDI
Identifiers
- Catalog Number
- 1116682 FDA UDI
- Primary DI / UDI-DI
- 00606959030718 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959030718 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 Under Nose Mask Large, Medium Frame w/Headgear, Global by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Rebreathing oxygen face mask.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
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- Ventlab — Ventlab Corp. · Class I
- 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-00606959030718 | 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 50f56a1f-4184-4386-96cb-a2d6748e3cc5 61 fields · synced Jun 18, 2026
- FDA UDI 13259072-a838-4256-a183-e86c27ca711d 36 fields · synced May 29, 2026
- EUDAMED 88655934-a1ea-4c17-94d7-406cb42b269e 61 fields · synced Jun 18, 2026