FDA.reportPublic FDA data

PSDS Bicarb Systems

Primary DI
00817492021068
Brand
PSDS Bicarb Systems
Company
MAR COR PURIFICATION, INC.
Model
PSDS,BICARB ONLY,HD
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FINTank, Holding, Dialysis

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492021068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492021068008174920210688174920210680817492021068

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
Depth48Inch
Height58Inch
Width110Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006333080info@mcpur.com

Regulatory Flags#

DUNS number
019056181
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492021297NAGENERATOR,O3Z,2.3GM/H2016-09-23
00817492021815NAGENERATOR,O3Z-E,0-4GM/HRNA2017-04-06
00817492020979MCB SeriesMCB 205-50 MF BICARB SEMI SYS2016-09-23
00817492020986MCB SeriesMCB 205-100 MF BICARB SEMI SYS2016-09-23
00817492020993MCB SeriesMCB 212-50 BICARB SEMI SYS2016-09-23
00817492021006MCB SeriesMCB 212-100 BICARB SEMI SYS2016-09-23
00817492021013MCB SeriesMCB 202-50 BICARB SNGL SYS2016-09-23
00817492021020MCB SeriesMCB 202-100 BICARB SNGL SYS2016-09-23
00817492021037MCB SeriesMIXER,BICARB,MCB202-50CD,SINGLE,50GAL2016-09-23
00817492021044MCB SeriesMCB 202-100 CD BICARB SNGL SYS2016-09-23
00817492021051PSDS Bicarb SystemsPSDS,BICARB ONLY2016-09-23
00817492021075PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB2016-09-23
00817492021082PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB,HD2016-09-23
00817492021099PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB2016-09-23
00817492021105PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB,HD2016-09-23
00817492021112PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB2016-09-23
00817492021129PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB,HD2016-09-23
00817492021136SDS Bicarb SystemsSDS,REMOTE,BICARB ONLY,HD,70G TANK2016-09-23
00817492021143SDS Bicarb SystemsSDS,REMOTE,1 ACID,1 BICARB,HD,70G TANK2016-09-23
00817492021150SDS Bicarb SystemsSDS,REMOTE,2 ACID,1 BICARB,HD,70G TANK2016-09-23

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
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