Home GUDID 37332414110575 BiCart
Primary DI 37332414110575
Brand BiCart
Company GAMBRO AB
Model 1250
Catalog number 114014
Device description Sodium Bicarbonate for Hemodialysis
Published 2015-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 37332414110575 Package GS1 6 In Commercial Distribution 07332414110574 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 37332414110575 37332414110575 07332414110574 07332414110574 7332414110574
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 Weight 1250 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 40 Degrees Celsius Storage Environment Temperature 0 Degrees Celsius 40 Degrees Celsius Storage Environment Temperature 0 104 Degrees Fahrenheit Storage Environment Temperature 0 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 354021099 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 false 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 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
baxter.com
vantive.com