Identity
- Trade Name
- SuperNO2VA FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- SuperNO2VA ET SYSTEM, Adult Medium FDA UDI
- Model / Reference
- SSEM-20 FDA UDI
- Description
- SuperNO2VA ET SYSTEM, Adult Medium FDA UDI
Identifiers
- Catalog Number
- SSEM-20 FDA UDI
- Primary DI / UDI-DI
- 10889483606049 FDA UDI
- FDA Product Code
- OEV FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP nasal mask, single-use
SuperNO2VA by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CPAP/BPAP nasal mask, single-use.
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- Whisper Soft — Engineered Medical Systems, LLC · Class II
- BiTrac — Pulmodyne Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Airlife, Inc.
Sources (1)
- FDA UDI 0f8d1da2-e352-47d5-8d3c-464d4d1bb0f7 35 fields · synced Jun 7, 2026