UltraViolet Light Disinfection System

Basic Information

• Brand Name: UltraViolet Light Disinfection System
• Primary DI: B297AU5057AF0
• Version / Model: A-U-5057-AF
• Company Name: SPECIALITY WATER TECHNOLOGY
• Labeler DUNS: 032528935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d6651007-3313-40d8-a9c9-8de7f10f624d

Device Description

Trojan Max/Viqua E-4 Plus UV disintection unit, 15 GPM, intensity meter and audible alarm. Includes bypass valves, air bleed valve & temperature probe. w/ auto-flush

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14438	Ultraviolet water purification system	An assembly of germicidal ultraviolet lamps with supplemental components designed to remove unwanted biological contaminants from water. This mains electricity (AC-powered) system purifies water by producing short-wave radiation lethal to bacteria, viruses, and other microorganisms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B297AU5057AF0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]