ENOBIO

Primary DI
08437017440796
Brand
ENOBIO
Company
NEUROELECTRICS BARCELONA SL
Model
WF
Device description
Enobio is a Wireless EEG, performs electroencephalographic measures with non-invasive technology.Enobio 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 use must be controlled by specialized medical personnel able to guarantee the correct recording.
Published
2019-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437017440796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437017440796084370174407968437017440796

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-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. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16176820770ana.maiques@neuroelectrics.com

Regulatory Flags#

DUNS number
463756944
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18437017440601Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440632Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440663Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18437017440687Enobio DxNG Pistim - Component Spare Part: Enobio Dx2023-09-14
18436612823031Enobio DxNeoprene Headcap (size L) - Component Spare Part: 2023-09-14
18436612823048Enobio DxNeoprene Headcap (size M) - Component Spare Part: 2023-09-14
18436612823055Enobio DxNeoprene Headcap (size S) - Component Spare Part: 2023-09-14
18436612823062Enobio DxNeoprene Headcap (size XL) - Component Spare Part:2023-09-14
18436612823079Enobio DxNeoprene Headband - Component Spare Part: Enobio D2023-09-14
08437017440390Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440618Enobio DxEarclip - Component Replacement: Enobio Dx2023-09-14
18437017440625Enobio DxForetrode - Component Replacement: Enobio Dx2023-09-14
08437017440383Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440656Enobio DxNG Geltrode - Component Replacement: Enobio Dx2023-09-14
08437017440376Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18437017440670Enobio DxNG Pistim - Component Replacement: Enobio Dx2023-09-14
08437017440406Enobio DxNG Pistim - Component Spare Part: Enobio Dx2023-09-14
18436612823000Enobio DxNeoprene Headcap (Kit, size M) - Component Replace2023-09-13
18436612823017Enobio DxKid Neoprene Headcap (size K) - Component Spare Pa2023-09-13
18436612823024Enobio DxKid Neoprene Headcap (size KS) - Component Spare P2023-09-13

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