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ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1070071
Identity
- Trade Name
- ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL EUDAMEDComfortGel Blue FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- ComfortGel Blue / ProFile Lite Family EUDAMEDComfortGel Blue Mask with Standard Elbow, with Headgear, Petite, International FDA UDI
- Model / Reference
- 1070071 EUDAMEDComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL FDA UDI
- Description
- ComfortGel Blue Mask with Standard Elbow, with Headgear, Petite, International FDA UDI
Identifiers
- Catalog Number
- 1070071 FDA UDI
- Primary DI / UDI-DI
- 00606959020832 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959020832 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
ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL 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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- 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-00606959020832 | 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 f23a8cf5-e421-4e09-8341-198d8f4909de 61 fields · synced Oct 6, 2026
- FDA UDI c89a70b1-5e08-454d-9842-56be129abc2c 36 fields · synced May 30, 2026
- EUDAMED 8c6e4dca-88d0-47d1-a848-217a7b008bc4 61 fields · synced Jul 20, 2026