Identity
- Trade Name
- UltraViolet Light Disinfection System FDA UDI
- Generic Name
- Ultraviolet water purification system FDA UDI
- Device Name
- Trojan Max/Viqua E-4 Plus UV disintection unit, 15GPM, thermal reduction valve, intensity meter and audible alarm. Includes bypass valves, air bleed valve & temperature probe. FDA UDI
- Model / Reference
- A-U-5057-THERM FDA UDI
- Description
- Trojan Max/Viqua E-4 Plus UV disintection unit, 15GPM, thermal reduction valve, intensity meter and audible alarm. Includes bypass valves, air bleed valve & temperature probe. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B297AU5057THERM0 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Ultraviolet water purification system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultraviolet water purification system
UltraViolet Light Disinfection System by Speciality Water Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet water purification system.
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · Class II
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · Class II
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · Class II
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · Class II
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · Class II
- UltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGY · 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
- Speciality Water Technology
Sources (1)
- FDA UDI 8120385b-f816-4c05-8c26-b6a5e008a18b 34 fields · synced May 30, 2026