Home GUDID B467CC313 DIASOL
Primary DI B467CC313
Brand DIASOL
Company DIASOL, INC.
Model CC31.3
Catalog number CC11
Device description Dialysate Additive 31.3 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
Published 2017-04-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 B467CC313115 Package HIBCC 115 In Commercial Distribution B467CC313 Primary HIBCC 0
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 31.3 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature
Regulatory Flags# DUNS number 068434658 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