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Mojo 2 Full Face AAV Non Vented Mask, Small
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 50941510(k) K190533
Identity
- Trade Name
- Mojo 2 Full Face AAV Non Vented Mask, Small EUDAMEDFDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Full Face Mask EUDAMEDFull face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation. FDA UDI
- Model / Reference
- 50941 EUDAMEDFDA UDI
- Description
- Full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747024089 EUDAMEDFDA UDI
- Basic UDI-DI
- 08147470215N2 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Mojo 2 Full Face AAV Non Vented Mask, Small by Sleepnet Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190533 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08147470215N2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
- EUDAMED SRN
- US-MF-000010620
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (3)
- EUDAMED 04b809a5-b71e-41cc-b07c-a3098038f836 85 fields · synced Jun 18, 2026
- FDA UDI 37ee5ec8-9b20-4c5c-9607-96c69c0685e7 35 fields · synced May 30, 2026
- FDA 510(k) K190533 1 fields · synced May 18, 2026