Home GUDID 00810104850063 AcetiCon
Primary DI 00810104850063
Brand AcetiCon
Company Global Scientific Technologies
Model AC2037-01-L
Catalog number AC2037-01-L
Device description AcetiCon Liquid Acid Concentrate for Bicarbonate Dialysis
Published 2022-03-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810104850063 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 00810104850063 00810104850063 810104850063 0810104850063
GMDN Terms# Term, Definition table Term Definition Haemodialysis concentrate 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.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 3.785 Liter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep container tightly closed when not in use.
Regulatory Flags# DUNS number 032473859 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10840861103055 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103062 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103079 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103086 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103093 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103109 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103116 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 10840861103123 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-12-18 00814963021503 CitraPure ROCKWELL MEDICAL, INC. KPO 2025-07-28 10840861102911 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-06-02 10840861102942 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2025-05-05 00814963021497 Dri-Sate ROCKWELL MEDICAL, INC. KPO 2025-02-06 10840861102829 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-10-10 00840861102839 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-10-10 10840861102843 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-10-10 10840861102850 Bicarby Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-10-10 10840861102768 PureFlow Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-05-30 10840861102775 PureFlow Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-05-30 10840861102782 PureFlow Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-05-30 10840861102799 PureFlow Fresenius Medical Care Renal Therapies Group, LLC KPO 2024-05-30 00817411023197 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-05-22 10814963020732 CitraPure ROCKWELL MEDICAL, INC. KPO 2024-04-18 10817411020018 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411020025 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411020032 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411023088 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411023095 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411023101 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411023118 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28 10817411023125 Citric Complete NIPRO RENAL SOLUTIONS USA CORPORATION KPO 2024-03-28
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