Identity
- Trade Name
- Innova Nasal Non Vented Mask, s/m FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- Nasal non vented mask for use with non invasive ventilator system with exhalation valve. FDA UDI
- Model / Reference
- 50592 FDA UDI
- Description
- Nasal non vented mask for use with non invasive ventilator system with exhalation valve. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747020791 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Innova Nasal Non Vented Mask, s/m by Sleepnet Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
Sources (1)
- FDA UDI 44a85689-a443-488e-8ec3-d849bf2da046 34 fields · synced Jun 9, 2026