Home GUDID 18436612820283 Enobio Dx
Primary DI 18436612820283
Brand Enobio Dx
Company NEUROELECTRICS BARCELONA SL
Model Enobio Dx 32
Device description Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording.
Published 2023-09-06
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name GWL Amplifier, Physiological Signal GWQ Full-Montage Standard Electroencephalograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWL Amplifier, Physiological Signal Neurology 2 GWQ Full-Montage Standard Electroencephalograph Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18436612820283 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 18436612820283 18436612820283
GMDN Terms# Term, Definition table Term Definition Electroencephalographic monitoring system An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 101.3 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 101.3 KiloPascal Storage Environment Humidity 15 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 463756944 Device count 1 Kit true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 18437017440601 Enobio Dx Drytrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440632 Enobio Dx Foretrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440663 Enobio Dx NG Geltrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440687 Enobio Dx NG Pistim - Component Spare Part: Enobio Dx 2023-09-14 18436612823031 Enobio Dx Neoprene Headcap (size L) - Component Spare Part: 2023-09-14 18436612823048 Enobio Dx Neoprene Headcap (size M) - Component Spare Part: 2023-09-14 18436612823055 Enobio Dx Neoprene Headcap (size S) - Component Spare Part: 2023-09-14 18436612823062 Enobio Dx Neoprene Headcap (size XL) - Component Spare Part: 2023-09-14 18436612823079 Enobio Dx Neoprene Headband - Component Spare Part: Enobio D 2023-09-14 08437017440390 Enobio Dx Drytrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440618 Enobio Dx Earclip - Component Replacement: Enobio Dx 2023-09-14 18437017440625 Enobio Dx Foretrode - Component Replacement: Enobio Dx 2023-09-14 08437017440383 Enobio Dx Foretrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440656 Enobio Dx NG Geltrode - Component Replacement: Enobio Dx 2023-09-14 08437017440376 Enobio Dx NG Geltrode - Component Spare Part: Enobio Dx 2023-09-14 18437017440670 Enobio Dx NG Pistim - Component Replacement: Enobio Dx 2023-09-14 08437017440406 Enobio Dx NG Pistim - Component Spare Part: Enobio Dx 2023-09-14 18436612823000 Enobio Dx Neoprene Headcap (Kit, size M) - Component Replace 2023-09-13 18436612823017 Enobio Dx Kid Neoprene Headcap (size K) - Component Spare Pa 2023-09-13 18436612823024 Enobio Dx Kid Neoprene Headcap (size KS) - Component Spare P 2023-09-13
Other Devices Sharing Product Codes# 
neuroelectrics.com