Enobio Dx

Primary DI
18436612823017
Brand
Enobio Dx
Company
NEUROELECTRICS BARCELONA SL
Model
Kid Neoprene Headcap (size K) - Component Spare Pa
Device description
This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size K). It is used to precisely place the electrodes on the scalp for stable recordings with Enobio Dx.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
2023-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162681000Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.2017-06-02GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18436612823017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1843661282301718436612823017

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn 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
TypeLowHighCondition
Special Storage Condition, Specify00Wash with cold water and soap. Hand wash. Do not use bleach-based chlorine. Do not ironing, steam treatments are not allowed. Line dry/ Hang to dry. Do not use dryer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34 932540366support@neuroelectrics.com

Regulatory Flags#

DUNS number
463756944
Device count
1
Kit
true
Lot or batch
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
18436612823024Enobio DxKid Neoprene Headcap (size KS) - Component Spare P2023-09-13
18436612820269Enobio DxEnobio Dx 82023-09-06

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