Identity
- Trade Name
- NanoVi FDA UDI
- Generic Name
- Non-heated respiratory humidifier FDA UDI
- Model / Reference
- NanoVi Eco Wellness FDA UDI
Identifiers
- Catalog Number
- 4650-00-W FDA UDI
- Primary DI / UDI-DI
- 00850005614029 FDA UDI
- FDA Product Code
- KFZ FDA UDI
- GMDN Term
- Non-heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5460 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-heated respiratory humidifier
NanoVi by Eng3 Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- B&F — Allied Medical LLC · Class II
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- Procure — Twin Med, LLC · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Eng3 Corporation
Sources (1)
- FDA UDI e7d28dbe-7919-43a2-afaa-e0a27c60f049 33 fields · synced Jun 9, 2026