Home GUDID B285SDSCB2001 BiPro Bicarb Mixing/Distribution System
Primary DI B285SDSCB2001
Brand BiPro Bicarb Mixing/Distribution System
Company MEDICAL SOLUTIONS INTERNATIONAL, INC.
Model SDS-CB200
Published 2017-06-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FIN Tank, Holding, Dialysis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FIN Tank, Holding, Dialysis Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B285SDSCB2001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haemodialysis system bicarbonate mixer An 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.
Sterilization Methods# Method table Method "[""Hydrogen Peroxide"", ""Ozone""]" Hydrogen Peroxide;Ozone
Regulatory Flags# DUNS number 926740010 Device count 1 Serial number true Sterilization required before use true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published BC0021 BICARB, DUAL, 100, MIX/DEL, EDUCTOR BETTER WATER, LLC FIN 2024-11-13 BC0121 BICARB, DUAL, 60, MIX/DEL, EDUCTOR BETTER WATER, LLC FIN 2024-11-13 00852456007085 Sodium Bicarbonate Mixing and Distribution System Isopure, Corp. FIN 2017-09-20 00817927020284 AmeriWater 00BCM55 AMERIWATER, LLC FIN 2017-01-10 00817927020291 AmeriWater 00BCM100 AMERIWATER, LLC FIN 2017-01-10 00817927020307 AmeriWater 00BCMD55 AMERIWATER, LLC FIN 2017-01-10 00817927020314 AmeriWater 00BCMD100 AMERIWATER, LLC FIN 2017-01-10 00817927020086 AmeriWater 0077-0010 Ozone Disinfection System AMERIWATER, LLC FIN 2017-01-06 00817927020055 AmeriWater 00BC55-55 Bicarb Mix and Distribution System AMERIWATER, LLC FIN 2017-01-05 00817927020062 AmeriWater 00BC100-100 Bicarb Mix and Distribution System AMERIWATER, LLC FIN 2017-01-05 00817927020079 AmeriWater 00BC100-200 Bicarb Mix and Distribution System AMERIWATER, LLC FIN 2017-01-05 00817492021785 MCB Series MAR COR PURIFICATION, INC. FIN 2016-12-29 00817492021310 MCB Series MAR COR PURIFICATION, INC. FIN 2016-10-28 BC0001 BICARB, DUAL, 100, MIX/DEL BETTER WATER, LLC FIN 2016-10-13 BC0002 BICARB, DUAL, 100, MIX/DEL/1000 BETTER WATER, LLC FIN 2016-10-13 BC0011 BICARB, DUAL, 100, MIX/DEL, SP BETTER WATER, LLC FIN 2016-10-13 BC0012 BICARB, DUAL, 100, MIX/DEL/1000, SP BETTER WATER, LLC FIN 2016-10-13 BC0101 BICARB, DUAL 60, MIX/DELV BETTER WATER, LLC FIN 2016-10-13 BC0111 BICARB, DUAL, 60, MIX/DEL, SP BETTER WATER, LLC FIN 2016-10-13 BC0201 BICARB, SINGLE, 100, MIX/DEL BETTER WATER, LLC FIN 2016-10-13 BC0202 BICARB, SINGLE, 100, MIX-ONLY BETTER WATER, LLC FIN 2016-10-13 BC0211 BICARB, SINGLE, 100, MIX/DEL, SP BETTER WATER, LLC FIN 2016-10-13 BC0301 BICARB, SINGLE, 60, MIX/DEL BETTER WATER, LLC FIN 2016-10-13 BC0302 BICARB, SINGLE, 60, MIX-ONLY BETTER WATER, LLC FIN 2016-10-13 00817492020979 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23 00817492020986 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23 00817492020993 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23 00817492021006 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23 00817492021013 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23 00817492021020 MCB Series MAR COR PURIFICATION, INC. FIN 2016-09-23