FDA.reportPublic FDA data

AmeriWater 00BCMD55

Primary DI
00817927020307
Brand
AmeriWater 00BCMD55
Company
AMERIWATER, LLC
Model
00BCMD55
Device description
00BCMD55 Single Tank Mix and Distribution Bicarb, 55 Gallon
Published
2017-01-10
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
K051031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051031000AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwater2006-01-06FIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817927020307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817927020307008179270203078179270203070817927020307

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system bicarbonate mixerAn electrically-powered integral unit of a haemodialysis system that mixes two concentrates, A and B, plus water, to the dialysis solution (dialysate) and monitors the mixture.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth31Inch
Height55Inch
Weight160Pound
Width43Inch

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""High-level Disinfectant""]"
Liquid Chemical;High-level Disinfectant

Regulatory Flags#

DUNS number
836758342
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817927020345AmeriWater Chemical Feed System0084-00050084-00052026-05-08
00817927020352AmeriWater Chemical Feed System0084-00060084-00062026-05-08
00817927020369AmeriWater Chemical Feed System0084-00070084-00072026-05-08
00817927020376AmeriWater Chemical Feed System0084-00220084-00222026-05-08
00817927020383AmeriWater® Alarm Panel00850250008502502026-05-08
00817927020390AmeriWater® Alarm Panel00850251008502512026-05-08
00817927020406AmeriWater® Alarm Panel00850252008502522026-05-08
00817927020413AmeriWater® Alarm Panel00850253008502532026-05-08
00817927020024AmeriWater Heatsan 00HS20800HS2082017-01-05
00817927020031AmeriWater Heatsan 00HS46000HS4602017-01-05
00817927020048AmeriWater Heatsan 00HS57500HS5752017-01-05
00817927020321AmeriWater MediQA 00MSP3HF-23000MSP3HF-2302023-06-07
00817927020338AmeriWater Water Purification System for HemodialysisComplete System2023-06-07
00817927020055AmeriWater 00BC55-55 Bicarb Mix and Distribution System00BC55-552017-01-05
00817927020062AmeriWater 00BC100-100 Bicarb Mix and Distribution System00BC100-1002017-01-05
00817927020079AmeriWater 00BC100-200 Bicarb Mix and Distribution System00BC100-2002017-01-05
00817927020284AmeriWater 00BCM5500BCM552017-01-10
00817927020291AmeriWater 00BCM10000BCM1002017-01-10
00817927020314AmeriWater 00BCMD10000BCMD1002017-01-10
00817927020000AmeriWater MROSMROS2017-01-05

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
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
BC0002BICARB, DUAL, 100, MIX/DEL/1000BETTER 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