FDA.reportPublic FDA data

BICARB, DUAL, 100, MIX/DEL/1000

Primary DI
BC0002
Brand
BICARB, DUAL, 100, MIX/DEL/1000
Company
BETTER WATER, LLC
Model
EQASSY100BC-1000FT
Catalog number
EQASSY100BC-1000FT
Device description
Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer loops.
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FINTank, Holding, Dialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FINTank, Holding, DialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992793000SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMBetter Water, Inc.1999-11-16FIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
BC0002PrimaryHIBCC0

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
PB0002MEDI-PORT PBII R.O. 220VEQROPB01600EQROPB016002024-11-13
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
BC0021BICARB, DUAL, 100, MIX/DEL, EDUCTORBETTER WATER, LLCFIN2024-11-13
BC0121BICARB, DUAL, 60, MIX/DEL, EDUCTORBETTER WATER, LLCFIN2024-11-13
00852456007085Sodium Bicarbonate Mixing and Distribution SystemIsopure, Corp.FIN2017-09-20
B285SDSCB2001BiPro Bicarb Mixing/Distribution SystemMEDICAL SOLUTIONS INTERNATIONAL, INC.FIN2017-06-30
00817927020284AmeriWater 00BCM55AMERIWATER, LLCFIN2017-01-10
00817927020291AmeriWater 00BCM100AMERIWATER, LLCFIN2017-01-10
00817927020307AmeriWater 00BCMD55AMERIWATER, LLCFIN2017-01-10
00817927020314AmeriWater 00BCMD100AMERIWATER, LLCFIN2017-01-10
00817927020086AmeriWater 0077-0010 Ozone Disinfection SystemAMERIWATER, LLCFIN2017-01-06
00817927020055AmeriWater 00BC55-55 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817927020062AmeriWater 00BC100-100 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817927020079AmeriWater 00BC100-200 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817492021785MCB SeriesMAR COR PURIFICATION, INC.FIN2016-12-29
00817492021310MCB SeriesMAR COR PURIFICATION, INC.FIN2016-10-28
BC0001BICARB, DUAL, 100, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0011BICARB, DUAL, 100, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0012BICARB, DUAL, 100, MIX/DEL/1000, SPBETTER WATER, LLCFIN2016-10-13
BC0101BICARB, DUAL 60, MIX/DELVBETTER WATER, LLCFIN2016-10-13
BC0111BICARB, DUAL, 60, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0201BICARB, SINGLE, 100, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0202BICARB, SINGLE, 100, MIX-ONLYBETTER WATER, LLCFIN2016-10-13
BC0211BICARB, SINGLE, 100, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0301BICARB, SINGLE, 60, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0302BICARB, SINGLE, 60, MIX-ONLYBETTER WATER, LLCFIN2016-10-13
00817492020979MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492020986MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492020993MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492021006MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492021013MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492021020MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23