Home GUDID 09349285000185 ACCUSOL Dialysis Solution for CRRT
Primary DI 09349285000185
Brand ACCUSOL Dialysis Solution for CRRT
Company Nikkiso Belgium BVBA
Model 30 2K+
Catalog number 5B9251
Device description Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Published 2016-06-30
Public version status Update
Distribution status Not 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 19349285000182 Package GS1 4 Not in Commercial Distribution 09349285000185 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 19349285000182 19349285000182 09349285000185 09349285000185 9349285000185
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 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 0 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 370482633 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09349285000154 ACCUSOL Dialysis Solution for CRRT 35 4K+ 5B9248 2016-06-30 09349285000161 ACCUSOL Dialysis Solution for CRRT 35 2K+ 5B9249 2016-06-30 09349285000178 ACCUSOL Dialysis Solution for CRRT 35 0K+ 0DEX 5B9250 2016-06-30 09349285000192 ACCUSOL Dialysis Solution for CRRT 30 2K+ 0Ca++ 5B9252 2016-06-30 09349285000208 Premixed Dialysate for Hemodiafiltration 5B7860 5B7860 2016-06-30
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