FDA.reportPublic FDA data

UltraViolet Light Disinfection System

Primary DI
B297AU50560
Brand
UltraViolet Light Disinfection System
Company
SPECIALITY WATER TECHNOLOGY
Model
A-U-5056
Device description
Trojan Max/Viqua Pro 20 UV Assembly-This assembly is designed to capture RO product water and loop return water before returning to holding tank. Equipped with check valves and pressure regulator. Easy plug N' play installation
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250514000UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.2025-03-17FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B297AU50560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet water purification systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-654-4441sales@specialtyh2o.com

Regulatory Flags#

DUNS number
032528935
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B297APT57250Hurricane Filter Assembly w/ Reject Assembly - DigitalA-PT-57252019-07-22
B297KAMT2A14306BT20Organic ScavengerK-A-MT-2A14-306-BT22019-07-22
B297AMTDI51500D.I.ControllerA-MT-DI-51502023-11-10
B297AMTDI5150SKID0Portable D.I.ControllerA-MT-DI-5150-SKID2023-11-10
B297S128970Digital pH BalancerS12897S128972022-08-23
B297KAPT5054D0Dual Big Blue Sediment FilterK-A-PT-5054-D2021-07-14
B297KAPTBV100125D0Blend Valve AssemblyK-A-PT-BV-100-125-D2021-07-14
B297KAMT7G521040Zeolite Filter TankK-A-MT-7G52-1042020-02-28
B297KAMT7H532050Zeolite Filter TankK-A-MT-7H53-2052020-02-28
B297KAMT7J543070Zeolite Filter TankK-A-MT-7J54-3072020-02-28
B297KAMT2A64306BT20Organic ScavengerK-A-MT-2A64-306-BT22020-02-26
B297KAMT2C66511BT30Organic ScavengerK-A-MT-2C66-511-BT32020-02-26
B297KAMT2C66512BT30Organic ScavengerK-A-MT-2C66-512-BT32020-02-26
B297KAMT2C66513BT30Organic ScavengerK-A-MT-2C66-513-BT32020-02-26
B297KAMT2C66514BT30Organic ScavengerK-A-MT-2C66-514-BT32020-02-26
B297KAMT2C66515BT30Organic ScavengerK-A-MT-2C66-515-BT32020-02-26
B297KAMT2Q65408BT20Organic ScavengerK-A-MT-2Q65-408-BT22020-02-26
B297KAMT2Q65409BT20Organic ScavengerK-A-MT-2Q65-409-BT22020-02-26
B297KAMT2Q65410BT20Organic ScavengerK-A-MT-2Q65-410-BT22020-02-26
B297KAMT2R62104BT10Organic ScavengerK-A-MT-2R62-104-BT12020-02-26

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