Home GUDID 24987671030218 Filter for dialysate purification
Primary DI 24987671030218
Brand Filter for dialysate purification
Company NIKKISO CO.,LTD.
Model EF-02D
Device description The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
Published 2025-04-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use false 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 24987671030218 Package GS1 6 In Commercial Distribution 04987671030214 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 24987671030218 24987671030218 04987671030214 04987671030214 4987671030214
GMDN Terms# Term, Definition table Term Definition Haemodialysis system dialysate pyrogen filter A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 4 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 39 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 690542378 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 true 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 04987671041517 HEMODIALYSIS DELIVERY SYSTEM DBB-06 2015-09-29 04987671060006 HEMODIALYSIS DELIVERY SYSTEM DBB-06 2016-08-12 04987671030214 Filter for dialysate purification EF-02D 2025-04-07 04987671041708 Hemodialysis Delivery System DBB-06 PRO 2025-08-22 04987671100627 Blood Tubing Lines for Hemodialysis AL-CDC-E(U) 2025-08-22 24987671041702 Hemodialysis Delivery System DBB-06 PRO 2025-08-22 24987671100621 Blood Tubing Lines for Hemodialysis AL-CDC-E(U) 2025-08-22 04987671100658 Blood Tubing Lines for Hemodialysis C18SFD-E(U) 2025-08-22 04987671400000 Blood Tubing Lines for Hemodialysis AV06C-E 2023-08-28 04987671201102 BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-P 2020-10-30 24987671201106 BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-P 2020-10-30
Other Devices Sharing Product Codes# 
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