Home GUDID 07332699000607 ISCUSflex
Primary DI 07332699000607
Brand ISCUSflex
Company M DIALYSIS INC.
Model Clinical
Catalog number 8003295
Device description Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
Published 2016-09-24
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 GWM Device, Monitoring, Intracranial Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWM Device, Monitoring, Intracranial Pressure Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07332699000744 Direct Marking GS1 0 07332699000607 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07332699000744 07332699000744 7332699000744 07332699000607 07332699000607 7332699000607
GMDN Terms# Term, Definition table Term Definition Microdialysis system analyser An instrument that may use one of several analytical techniques (e.g., spectrophotometry) to determine and display the concentration of analytes (e.g., glucose, lactate, pyruvate) in an interstitial fluid dialysate sample, as part of an assembly of devices used to monitor local body-tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 500 millibar 1060 millibar Handling Environment Humidity 10 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Handling Environment Temperature 18 Degrees Celsius 28 Degrees Celsius Storage Environment Atmospheric Pressure 500 millibar 1060 millibar Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 824632087 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07332699000911 70 Brain Microdialysis Catheter 60/10, 4/pkg 60/10 P000049 2016-09-24 07332699000928 70 Brain Microdialysis Catheter 100/10, 4/pkg 100/10 P000050 2016-09-24 07332699000973 70 Microdialysis Bolt Catheter 130/10, 4/pkg 130/10 P000131 2016-09-24 07332699000300 Reagent Kit Reagent P000011 2016-09-24 07332699000331 Reagent Set A Reagent 8002163 2016-09-24 07332699000348 Reagent Set B Reagent 8002164 2016-09-24 07332699000355 Reagent Set C Reagent 8002165 2016-09-24 07332699000461 Calibrator A Calibrator P000057 2016-09-24 07332699000744 ISCUSflex Clinical 8003295 2016-09-24 07332699000621 L-P-G Reagent kit Reagent 8010361 2016-09-24 07332699000546 70 Brain Microdialysis Catheter 60/10, 4/pkg 60/10 P000049 2016-09-24 07332699000539 70 Brain Microdialysis Catheter 100/10, 4/pkg 100/10 P000050 2016-09-24 07332699000577 70 Microdialysis Bolt Catheter 130/10, 4/pkg 130/10 P000131 2016-09-24 07332699000034 106 Microdialysis Pump 106 P000003 2016-09-24 07332699000058 Battery 2x3V, 106 MD Pump 106 8001788 2016-09-24 07332699000072 106 Syringe 106 8010191 2016-09-24 07332699000249 Microvial rack 12/pkg Rack P000028 2016-09-24 07332699000256 Microvials 250/pkg 250 x Microvial P000001 2016-09-24 07332699000263 Perfusion fluid CNS CNS P000151 2016-09-24 07332699000287 Glutamate reagent 5 x Reagent, 5 x Buffer P000064 2016-09-24
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