Home GUDID 50085412079115 ACCUSOL Dialysis Solution for CRRT
Primary DI 50085412079115
Brand ACCUSOL Dialysis Solution for CRRT
Company BAXTER INTERNATIONAL INC.
Model 35 4K+
Catalog number 5B9248
Device description Accusol 35 4K+ Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Published 2015-10-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 50085412079115 Package GS1 4 Not in Commercial Distribution 00085412079110 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 50085412079115 50085412079115 00085412079110 00085412079110 085412079110 0085412079110
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 2500 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature (25 C/77 F). Avoid excessive heat. Brief exposure up to 40 C (104 F) does not adversely affect the product. Protect from freezing. Storage Environment Temperature 0 25 Degrees Celsius Storage Environment Temperature 0 77 Degrees Fahrenheit Storage Environment Temperature 0 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 005146311 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
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