Home GUDID 00898021000037 Maky 21.1
Primary DI 00898021000037
Brand Maky 21.1
Company Angelini Pharma Inc.
Model 21.1
Catalog number MAKY21.1
Device description Dialyzer reprocessing machine.
Published 2016-08-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LIF Dialyzer Reprocessing System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIF Dialyzer Reprocessing System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00898021000037 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 00898021000037 00898021000037 898021000037 0898021000037
GMDN Terms# Term, Definition table Term Definition Haemodialysis dialyser reprocessing system An assembly of mains electricity (AC-powered) devices designed to clean and disinfect haemodialysis dialyzers after each use so that they can be reused, usually by the same patient. It typically performs a cycle that includes rinsing the dialyser with water/cleaning agent [e.g., hydrogen peroxide (H2O2)]; reverse ultrafiltration cleaning; disinfection or re-sterilization (e.g., with formaldehyde); labelling; and performance testing (e.g., volume, pressure). The complete cycle may be performed on one dialyser at a time or several at once (i.e., a single- or multiple-station system). The system may include computing capabilities or be attached to a personal computer for operation.
Regulatory Flags# DUNS number 078843940 Device count 1 Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G212GT23101 GlutarTest 1 Ibt Scientific LLC LIF 2022-01-06 00851575007389 Stericide Peroxide Reagent Strips HACH COMPANY LIF 2020-04-14 00677964007972 Renalin Residual Test Strips MEDIVATORS INC. LIF 2018-07-09 10677964007979 Renalin Residual Test Strips MEDIVATORS INC. LIF 2018-07-09 10677964009119 Perassay 500 Peracetic Acid Test Strips MEDIVATORS INC. LIF 2018-07-09 00898021000235 PeraSidual Angelini Pharma Inc. LIF 2017-05-23 00898021000242 PeraChek Angelini Pharma Inc. LIF 2017-05-23 00382830034456 NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATED LIF 2017-03-17 00858293006120 Micro-X REPROCESSING PRODUCTS CORPORATION LIF 2017-03-07 00851575007044 SteriChek® Peroxide Reagent Strips HACH COMPANY LIF 2016-09-23 00851575007075 SteriChek® Residual Peroxide Reagent Strips HACH COMPANY LIF 2016-09-23 00851575007150 SteriChek® Peracetic Acid Reagent Strips HACH COMPANY LIF 2016-09-23 M17451051 Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATION LIF 2016-09-08 M17451052 Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATION LIF 2016-09-08 M17451121 Serim® GUARDIAN™ Residual Formaldehyde Test Strips SERIM RESEARCH CORPORATION LIF 2016-09-08
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