FDA.reportPublic FDA data

"FILTER, RENAPURE 20"" 222 FIN"

Primary DI
00817492021792
Brand
"FILTER, RENAPURE 20"" 222 FIN"
Company
Evoqua Water Technologies Corp.
Model
W3T590099
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
K231410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231410000RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC2023-07-19FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492021792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492021792008174920217928174920217920817492021792

GMDN Terms#

Term, Definition table
TermDefinition
Microbial water purification filter, non-sterilizableA sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079427087
Device count
1
Expiration date on label
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
00817492022508RO, MIILENIUM HX, 4118, 115~, 60HZW3T5777492024-05-17
00817492023703"FILTER, RENAPURE 20"" 222 FLAT"W3T5901002024-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
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
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
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
04251285200524AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200531AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200562AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200579AquaB LITEVIVONIC GmbHFIP2024-07-25