FDA.reportPublic FDA data

Loop Distribution System

Primary DI
B297KAUPT33B1AXD0
Brand
Loop Distribution System
Company
SPECIALITY WATER TECHNOLOGY
Model
K-A-UPT-33B1A-X-D
Device description
250 Gallon Ultra-Pure Distribution System w/ Variable Frequency Control. Features: calibration scale, pedestal stand, Digital flow monitor w/ velocity readout, Loop conductivity monitor with set-point, Disinfect mode, digital pressure transmitter, sanitary sampling port, injection assembly, run dry protection, flow regulator, 316 SS distribution pump (3Ph) 3 hp w/ VFD controller.
Published
2017-10-05
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
B297KAUPT33B1AXD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Combination water purification systemAn assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
032528935
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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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