Home GUDID 00840861102914 Bicarby
Primary DI 00840861102914
Brand Bicarby
Company Fresenius Medical Care Renal Therapies Group, LLC
Model RFP-404-G
Device description Bicarby Dialysate RFP-404
Published 2025-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
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 10840861102911 Package GS1 2 In Commercial Distribution 00840861102914 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 10840861102911 10840861102911 00840861102914 00840861102914 840861102914 0840861102914
GMDN Terms# Term, Definition table Term Definition Haemodialysis dialysate solution A sterile, ready-to-use solution with an electrolyte composition similar to that of blood (i.e., a dialysate) intended to exchange solutes with blood across a semi-permeable membrane. It is used within a haemodialysis system to remove metabolic wastes from the blood and 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, lactate]. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 5000 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 079732391 Device count 1 Lot or batch true Manufacturing date on label true Expiration 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 10857940006671 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2022-02-24 10857940006688 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2022-02-24 38051411600351 HMB32 HAEMOPHARM BIOFLUIDS SRL KPO 2021-07-03 38051411600061 HMB32 HAEMOPHARM BIOFLUIDS SRL KPO 2020-03-11 M535RFP211WW0 NxStage PureFlow Solution NXSTAGE MEDICAL, INC. KPO 2018-10-01 10857940006664 HEMO-DIAL EDLAW PHARMACEUTICALS, INC. KPO 2017-12-22 10857940006657 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2017-10-06 10857940006640 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2017-10-04 10857940006633 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2017-04-17 10857940006626 Hemo-Dial EDLAW PHARMACEUTICALS, INC. KPO 2017-03-15 B46710013075100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710020010100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710021075100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710021575100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710023510100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710031075100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710031575100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710032010100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710032075100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710032525100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710033510100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710033575100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710042075100 DIASOL DIASOL, INC. KPO 2017-02-28 B467100422575100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710043075100 DIASOL DIASOL, INC. KPO 2017-02-28 B46710043575100 DIASOL DIASOL, INC. KPO 2017-02-28 B4677811510200 DIASOL DIASOL, INC. KPO 2017-02-28 B4677812010200 DIASOL DIASOL, INC. KPO 2017-02-28 B4677821510200 DIASOL DIASOL, INC. KPO 2017-02-28 B4677822010200 DIASOL DIASOL, INC. KPO 2017-02-28