FDA.reportPublic FDA data

MEDI-PORT PBII R.O. 220V

Primary DI
PB0002
Brand
MEDI-PORT PBII R.O. 220V
Company
BETTER WATER, LLC
Model
EQROPB01600
Catalog number
EQROPB01600
Device description
Portable reverse osmosis machine for water purification for dialysis applications. 220V.
Published
2024-11-13
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
K954928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954928000PORTABLE REVERSE OSMOSIS MACHINEBetter Water, Inc.1996-01-24FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
PB0002PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
055252159
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
RO0258E-2436RO, 8640GPD, 208V, 4MEMEQRME-248K-3LEQRME-248K-3L2024-11-13
BC0021BICARB, DUAL, 100, MIX/DEL, EDUCTOREQASSY100BC-2TNK-EBEQASSY100BC-2TNK-EB2024-11-13
BC0121BICARB, DUAL, 60, MIX/DEL, EDUCTOREQASSY60BC-2TNK-EBEQASSY60BC-2TNK-EB2024-11-13
PB0003MEDI-PORT PBII R.O. 120VEQROPB01613EQROPB016132024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"WM-PRE-4103-CSAWM-PRE-4103-CSA2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"WM-PST-303-OO-1GJWM-PST-303-OO-1GJ2024-11-13
BC0001BICARB, DUAL, 100, MIX/DELEQASSY100BC-2TNKEQASSY100BC-2TNK2016-10-13
BC0002BICARB, DUAL, 100, MIX/DEL/1000EQASSY100BC-1000FTEQASSY100BC-1000FT2016-10-13
BC0011BICARB, DUAL, 100, MIX/DEL, SPEQASSY100BC-2TNK-SPEQASSY100BC-2TNK-SP2016-10-13
BC0012BICARB, DUAL, 100, MIX/DEL/1000, SPEQASSY100BC-1000SPEQASSY100BC-1000SP2016-10-13
BC0101BICARB, DUAL 60, MIX/DELVEQASSY60BC-2TNKEQASSY60BC-2TNK2016-10-13
BC0111BICARB, DUAL, 60, MIX/DEL, SPEQASSY60BC-2TNK-SPEQASSY60BC-2TNK-SP2016-10-13
BC0201BICARB, SINGLE, 100, MIX/DELEQASSY100BC-1TNKEQASSY100BC-1TNK2016-10-13
BC0202BICARB, SINGLE, 100, MIX-ONLYEQASSY100BICARBEQASSY100BICARB2016-10-13
BC0211BICARB, SINGLE, 100, MIX/DEL, SPEQASSY100BC-1TNK-SPEQASSY100BC-1TNK-SP2016-10-13
BC0301BICARB, SINGLE, 60, MIX/DELEQASSY60BC-1TNKEQASSY60BC-1TNK2016-10-13
BC0302BICARB, SINGLE, 60, MIX-ONLYEQASSY60BICARBEQASSY60BICARB2016-10-13
PS0105POSTTREAT, 4UF, 230V, DTDWM-PST-340-RM-2GDWM-PST-340-RM-2GD2019-06-28
PR0011"MATRIX -PRETREAT, 1"", 230V, CPVC"WM-PRE-4101-CMWM-PRE-4101-CM2019-06-28
PR0012"MATRIX-PRETREAT, 1"" 208V, CPVC"WM-PRE-4103-CMWM-PRE-4103-CM2019-06-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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
04251285200586AquaB LITEVIVONIC GmbHFIP2024-07-25