Home GUDID 04039361001117 Hemoflow™
Primary DI 04039361001117
Brand Hemoflow™
Company Fresenius Medical Care AG & Co. KGaA
Model 0500714S
Device description F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL
Published 2015-10-23
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 KDI Dialyzer, high permeability with or without sealed dialysate system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04039361001117 Package GS1 12 Not in Commercial Distribution 04039361001100 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04039361001117 04039361001117 4039361001117 04039361001100 04039361001100 4039361001100
GMDN Terms# Term, Definition table Term Definition Hollow-fibre haemodialysis dialyser, single-use A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Area/Surface Area 0.7 Square meter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 324661834 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04039361001391 Diasafe 5008201 5008203 2015-10-23
Other Devices Sharing Product Codes# 
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