Mojo 2 Full Face AAV Non Vented Mask, Medium
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Mojo 2 Full Face Non Vented Mask, Medium EUDAMEDFDA UDIMojo 2 Full Face AAV Non Vented Mask, Medium FDA 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 UDIFull face non vented mask for use in positive pressure ventilation. FDA UDI
- Model / Reference
- 50913 EUDAMEDFDA UDI50942 FDA UDI
- Description
- Full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation. FDA UDIFull face non vented mask for use in positive pressure ventilation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747024058 EUDAMEDFDA UDI00814747024096 FDA UDI
- Basic UDI-DI
- 08147470221MV 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: CPAP/BPAP face mask, reusable
Mojo 2 Full Face AAV Non Vented Mask, Medium by Sleepnet Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
Sources (3)
- FDA UDI f262b2b4-c77b-411c-ba3b-6a8257818f62 35 fields · synced Sep 18, 2026
- FDA UDI 2e68af44-0709-46bb-8706-dce329b06ea8 35 fields · synced May 30, 2026
- EUDAMED 4d389863-087c-4d42-b38b-de0a1d2524e4 61 fields · synced Sep 18, 2026