Home GUDID 08437017440383 Enobio Dx
Primary DI 08437017440383
Brand Enobio Dx
Company NEUROELECTRICS BARCELONA SL
Model Foretrode - Component Spare Part: Enobio Dx
Device description This device is the spare part of Enobio Dx's component Foretrode. Foretrode is an EEG electrode to be used with Enobio Dx on bare-skin scalp areas, like the forehead. 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 2023-09-14
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GWQ Full-Montage Standard Electroencephalograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWQ Full-Montage Standard Electroencephalograph Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18437017440632 Primary GS1 0 08437017440383 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18437017440632 18437017440632 08437017440383 08437017440383 8437017440383
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 Humidity 15 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius 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 8 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 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 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 18436612820269 Enobio Dx Enobio Dx 8 2023-09-06
Other Devices Sharing Product Codes# 
neuroelectrics.com