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M Comfortgel Blue Se Nasal Mask W/Hgr, Intl
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1070069Model ComfortGel Blue Nasal Mask
Identity
- Trade Name
- M COMFORTGEL BLUE SE NASAL MASK W/HGR, INTL EUDAMEDComfortGel FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- ComfortGel Blue Mask with Standard Elbow, with Headgear, Medium, International FDA UDI
- Model / Reference
- ComfortGel Blue Nasal Mask EUDAMED1070069 EUDAMEDComfortGel Blue Mask w/SE, w/Headgear, Medium, INTL FDA UDI
- Description
- ComfortGel Blue Mask with Standard Elbow, with Headgear, Medium, International FDA UDI
Identifiers
- Catalog Number
- 1070069 FDA UDI
- Primary DI / UDI-DI
- 00606959022249 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959022249 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
M Comfortgel Blue Se Nasal Mask W/Hgr, Intl by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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-00606959022249 | 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 d48e958b-12d7-4e22-83c6-9dd6bed39e87 61 fields · synced Jul 8, 2026
- FDA UDI 262b0a32-4a69-4f23-9495-8af136bb2b97 36 fields · synced May 29, 2026
- EUDAMED 160b5745-f54e-4ea6-83f5-d1983edd4079 61 fields · synced Jul 8, 2026