Identity
- Trade Name
- Ascend Full Face Vented Mask, Small EUDAMEDFDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Full Face Mask EUDAMEDFull face vented mask for use in positive pressure ventilation. FDA UDI
- Model / Reference
- 50801 EUDAMEDFDA UDI
- Description
- Full face vented mask for use in positive pressure ventilation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747024140 EUDAMEDFDA UDI
- Basic UDI-DI
- 08147470207N3 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 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
Ascend Full Face Vented Mask, Small by Sleepnet Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08147470207N3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
- EUDAMED SRN
- US-MF-000010620
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED c08aa704-c362-41ae-a084-2e669b893450 61 fields · synced Jun 9, 2026
- FDA UDI 0b8400f9-d5de-473b-8ac2-37e16eed6653 35 fields · synced May 30, 2026