Home GUDID 07332699000355 Reagent Set C
Primary DI 07332699000355
Brand Reagent Set C
Company M DIALYSIS INC.
Model Reagent
Catalog number 8002165
Device description Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette.
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 PPM General Purpose Reagent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPM General Purpose Reagent Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07332699000355 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07332699000355 07332699000355 7332699000355
GMDN Terms# Term, Definition table Term Definition Microdialysis system An assembly of devices intended to be 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. The assembly typically includes a dedicated catheter that is inserted/implanted into tissue (e.g., brain, liver, muscle), a pump that circulates perfusion fluid and interstitial fluid dialysate to and from the site of monitoring, a small vial(s) used to collect samples of dialysate, and an analyser used to determine and display concentrations of analytes (e.g., glucose, lactate, pyruvate) in dialysate samples.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 824632087 Device count 1 DM exempt true Kit true Combination product true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07332699000607 ISCUSflex Clinical 8003295 2016-09-24 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 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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