FDA.reportPublic FDA data

Haemodialysis concentrate

Definition
A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.
GUDID devices
1,018
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00085412007380Premixed Dialysate for HemodiafiltrationBAXTER INTERNATIONAL INC.5B78602015-10-24
00085412079110ACCUSOL Dialysis Solution for CRRTBAXTER INTERNATIONAL INC.35 4K+2015-10-24
00085412079127ACCUSOL Dialysis Solution for CRRTBAXTER INTERNATIONAL INC.35 2K+2015-10-24
00085412079134ACCUSOL Dialysis Solution for CRRTBAXTER INTERNATIONAL INC.35 0K+ 0DEX2015-10-24
00085412079141ACCUSOL Dialysis Solution for CRRTBAXTER INTERNATIONAL INC.30 2K+2015-10-24
00085412083018ACCUSOL Dialysis Solution for CRRTBAXTER INTERNATIONAL INC.30 2K+ 0Ca++2015-10-24
00677964000300Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.MB-3302016-09-20
00677964000317Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.MB-330-152016-09-20
00677964000324Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.MB-330-252016-09-20
00677964000331Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.BC-12016-09-20
00677964000348Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.BC-1-152016-09-20
00677964000355Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.BC-1-252016-09-20
00677964000393Renasol Liquid Bicarbonate ConcentrateMEDIVATORS INC.BC-1-L2016-09-20
00677964000409Centrisol Liquid Bicarbonate ConcentrateMEDIVATORS INC.MB-330-L2016-09-20
00677964000485Centrisol Acid ConcentrateMEDIVATORS INC.SB-1112016-09-20
00677964000492Centrisol Acid ConcentrateMEDIVATORS INC.SB-1192016-09-20
00677964000508Centrisol Acid ConcentrateMEDIVATORS INC.SB-1232016-09-20
00677964000515Centrisol Acid ConcentrateMEDIVATORS INC.SB-1272016-09-20
00677964000522Centrisol Acid ConcentrateMEDIVATORS INC.SB-1292016-09-20
00677964000539Centrisol Acid ConcentrateMEDIVATORS INC.SB-1302016-09-20
00677964000546Centrisol Acid ConcentrateMEDIVATORS INC.SB-1372016-09-20
00677964000553Centrisol Acid ConcentrateMEDIVATORS INC.SB-1402016-09-20
00677964000560Centrisol Acid ConcentrateMEDIVATORS INC.SB-1422016-09-20
00677964000577Centrisol Acid ConcentrateMEDIVATORS INC.SB-1432016-09-20
00677964000584Centrisol Acid ConcentrateMEDIVATORS INC.SB-1442016-09-20
00677964000591Centrisol Acid ConcentrateMEDIVATORS INC.SB-1452016-09-20
00677964000607Centrisol Acid ConcentrateMEDIVATORS INC.SB-1512016-09-20
00677964000614Centrisol Acid ConcentrateMEDIVATORS INC.SB-1522016-09-20
00677964000621Renasol Acid ConcentrateMEDIVATORS INC.SB-10032016-09-20
00677964000669Renasol Acid ConcentrateMEDIVATORS INC.SB-10142016-09-20
00677964000676Renasol Acid ConcentrateMEDIVATORS INC.SB-10192016-09-20
00677964000683Renasol Acid ConcentrateMEDIVATORS INC.SB-10202016-09-20
00677964000713Renasol Acid ConcentrateMEDIVATORS INC.SB-10302016-09-20
00677964000720Renasol Acid ConcentrateMEDIVATORS INC.SB-10572016-09-20
00677964000737Renasol Acid ConcentrateMEDIVATORS INC.SB-10632016-09-20
00677964000744Renasol Acid ConcentrateMEDIVATORS INC.SB-10702016-09-20
00677964000751Renasol Acid ConcentrateMEDIVATORS INC.SB-10762016-09-20
00677964000768Renasol Acid ConcentrateMEDIVATORS INC.SB-10772016-09-20
00677964000775Renasol Acid ConcentrateMEDIVATORS INC.SB-10782016-09-20
00677964000812Renasol Acid ConcentrateMEDIVATORS INC.SB-10862016-09-20
00677964044274Centrisol Acid ConcentrateMEDIVATORS INC.SB-3522016-09-20
00677964044298Centrisol Acid ConcentrateMEDIVATORS INC.SB-3512016-09-20
00677964044311Centrisol Acid ConcentrateMEDIVATORS INC.SB-3442016-09-20
00677964044342Centrisol Acid ConcentrateMEDIVATORS INC.SB-3422016-09-20
00677964044366Centrisol Acid ConcentrateMEDIVATORS INC.SB-3302016-09-20
00677964056451Centrisol Acid ConcentrateMEDIVATORS INC.SB-1642016-09-20
00677964068171Outset Acid ConcentrateMEDIVATORS INC.A-2252016-09-20
00677964068188Outset Acid ConcentrateMEDIVATORS INC.A-3252016-09-20
00677964068195Outset Liquid Bicarbonate ConcentrateMEDIVATORS INC.B-1002016-09-20
00677964091766Centrisol Acid ConcentrateMEDIVATORS INC.SB-3532018-06-15
00810104850001AcetiConGlobal Scientific TechnologiesAC2034-01-L2022-03-10
00810104850032AcetiConGlobal Scientific TechnologiesAC2035-01-L2022-03-10
00814963020735CitraPureROCKWELL MEDICAL, INC.L4-1282024-04-18
00814963021169CitraPureROCKWELL MEDICAL, INC.L3-1342015-09-28
00814963021176CitraPureROCKWELL MEDICAL, INC.L3-1452015-09-28
00814963021220CitraPureROCKWELL MEDICAL, INC.L4-011C2016-05-09
00814963021237CitraPureROCKWELL MEDICAL, INC.L4-022C2016-05-09
00814963021244CitraPureROCKWELL MEDICAL, INC.L4-033C2016-05-09
00814963021268CitraPureROCKWELL MEDICAL, INC.L4-055C2016-05-09
00814963021275CitraPureROCKWELL MEDICAL, INC.L4-066C2016-05-09
0081496302130530% Acetic Acid SolutionROCKWELL MEDICAL, INC.R-3002016-06-13
00814963021336RenalPureROCKWELL MEDICAL, INC.C-2162017-01-20
00814963021343RenalPureROCKWELL MEDICAL, INC.C-2242017-01-20
00814963021350RenalPureROCKWELL MEDICAL, INC.C-1292017-08-08
00814963021367RenalPureROCKWELL MEDICAL, INC.C-1252017-09-07
00814963021374RenalPureROCKWELL MEDICAL, INC.C-1302017-09-07
00814963021480RenalPureROCKWELL MEDICAL, INC.C-1312019-06-17
00817411020011Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONLC+2002024-03-28
00817411020028Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONLC+2012024-03-28
00817411020035Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONLC+2022024-03-28
00817411020066MedicaPureDIMESOL USA, LLCAC-2012017-03-23
00817411020080MedicaPureDIMESOL USA, LLCAC-2022017-03-23
00817411020165MedicaPureDIMESOL USA, LLCAC-2062016-12-12
00817411020240MedicaLyteDIMESOL USA, LLCBC-1002017-03-23
00817411020257MedicaLyteDIMESOL USA, LLCBC-2012016-11-11
00817411020264MedicaLyteDIMESOL USA, LLCBC-3002018-07-25
00817411020271MedicaLyteDIMESOL USA, LLCDB-100-2.52017-03-23
00817411020325MedicaLyteDIMESOL USA, LLCDB-201-252016-11-11
00817411020332MedicaPureDIMESOL USA, LLCAC-1002018-07-25
00817411020431MedicaPureDIMESOL USA, LLCAC-1052016-12-12