Varifit NIV Non Vented Mask, Extra Large Adult
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VariFit NIV Non Vented Mask, Extra Large EUDAMEDVarifit NIV Non Vented Mask, Extra Large Adult FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Full Face Mask EUDAMEDDisposable full face non vented mask for use in positive pressure ventilation. FDA UDI
- Model / Reference
- 22790 EUDAMEDFDA UDI
- Description
- Disposable full face non vented mask for use in positive pressure ventilation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747024577 EUDAMEDFDA UDI00814747021293 FDA UDI
- Basic UDI-DI
- 08147470217N6 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Lithuania 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
No
Manufacturing Date
Yes
Category: CPAP/BPAP face mask, single-use
Varifit NIV Non Vented Mask, Extra Large Adult 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 eb01d055-1544-45ab-b45e-f74096a0ecc1 34 fields · synced Sep 30, 2026
- FDA UDI 1e50dc15-c280-48c0-a047-599025c9bdbc 35 fields · synced May 30, 2026
- EUDAMED a68a3d80-2d3c-4161-8cfb-42e65e7ddee6 61 fields · synced Sep 30, 2026