Home GUDID 00852456007085 Sodium Bicarbonate Mixing and Distribution System
Primary DI 00852456007085
Brand Sodium Bicarbonate Mixing and Distribution System
Company Isopure, Corp.
Model IsoMix PRO
Device description IsoMix PRO Sodium Bicarbonate Mixing and Distribution System (MD702480-SS)
Published 2017-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true 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 00852456007085 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00852456007085 00852456007085 852456007085 0852456007085
GMDN Terms# Term, Definition table Term Definition Haemodialysis system fluid mixer An electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture.
Regulatory Flags# DUNS number 040279650 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# 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 B285SDSCB2001 BiPro Bicarb Mixing/Distribution System MEDICAL SOLUTIONS INTERNATIONAL, INC. FIN 2017-06-30 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