FDA.reportPublic FDA data

RO, MIILENIUM HX, 4118, 115~, 60HZ

Primary DI
00817492022508
Brand
RO, MIILENIUM HX, 4118, 115~, 60HZ
Company
Evoqua Water Technologies Corp.
Model
W3T577749
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K192398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192398000Millenium HXMar Cor Purification, Inc.2019-10-03FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492022508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492022508008174920225088174920225080817492022508

GMDN Terms#

Term, Definition table
TermDefinition
Reverse-osmosis water purification systemAn assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit90 Degrees Fahrenheit
Storage Environment Temperature36 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079427087
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492023710RO, EON, 115~, 50/60HZW3T5783482024-05-29
B486W5TDICAR0025FFQR0SDI EXCHANGE TANK 0.25 CU/FT CARBON BC1240W5TDICAR0025FFQR2024-05-22
B486W5TDICAR0045FFQR0SDI EXCHANGE TANK 0.45 CU/FT CARBON BC1240W5TDICAR0045FFQR2024-05-22
B486W5TDICAR0054FFQR0SDI EXCHANGE TANK 0.54 CU/FT CARBON BC1240W5TDICAR0054FFQR2024-05-22
B486W5TDICAR0079FFQR0SDI EXCHANGE TANK 0.79 CU/FT CARBON BC1240W5TDICAR0079FFQR2024-05-22
B486W5TDICAR0360FSQR0SDI EXCHANGE TANK 3.6 CU/FT CARBON BC1240W5TDICAR0360FSQR2024-05-22
B486W5TDICAR0500FSQR0SDI EXCHANGE TANK 5.0 CU/FT CARBON BC1240W5TDICAR0500FSQR2024-05-22
B486W5TDICAR0600FSQR0SDI EXCHANGE TANK 6.0 CU/FT CARBON BC1240W5TDICAR0600FSQR2024-05-22
B486W5TDICAT0025FFQR0SDI EXCHANGE TANK 0.25 CU/FT CATION RESINW5TDICAT0025FFQR2024-05-22
B486W5TDILIG0025FFQR0SDI EXCHANGE TANK 0.25 CU/FT CARBON LIGNITEW5TDILIG0025FFQR2024-05-22
B486W5TDILIG0045FFQR0SDI EXCHANGE TANK 0.45 CU/FT CARBON LIGNITEW5TDILIG0045FFQR2024-05-22
B486W5TDILIG0054FFQR0SDI EXCHANGE TANK 0.54 CU/FT CARBON LIGNITEW5TDILIG0054FFQR2024-05-22
B486W5TDILIG0079FFQR0SDI EXCHANGE TANK 0.79 CU/FT CARBON LIGNITEW5TDILIG0079FFQR2024-05-22
B486W5TDILIG0360FSQR0SDI EXCHANGE TANK 3.6 CU/FT CARBON LIGNITEW5TDILIG0360FSQR2024-05-22
B486W5TDILIG0500FSQR0SDI EXCHANGE TANK 5.0 CU/FT CARBON LIGNITEW5TDILIG0500FSQR2024-05-22
B486W5TDILIG0600FSQR0SDI EXCHANGE TANK 6.0 CU/FT CARBON LIGNITEW5TDILIG0600FSQR2024-05-22
B486W5TDIMB10045FFQR0SDI EXCHANGE TANK 0.45 CU/FT MIXED BED RESINW5TDIMB10045FFQR2024-05-22
B486W5TDIMB10360FSQR0SDI EXCHANGE TANK 3.6 CU/FT MIXED BED RESINW5TDIMB10360FSQR2024-05-22
00817492021792"FILTER, RENAPURE 20"" 222 FIN"W3T5900992024-05-17
00817492023703"FILTER, RENAPURE 20"" 222 FLAT"W3T5901002024-05-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
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00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
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00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
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00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"BETTER WATER, LLCFIP2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
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04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
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04251285200579AquaB LITEVIVONIC GmbHFIP2024-07-25