FDA.reportPublic FDA data

Enobio Dx

Primary DI
08437017440376
Brand
Enobio Dx
Company
NEUROELECTRICS BARCELONA SL
Model
NG Geltrode - Component Spare Part: Enobio Dx
Device description
This device is the spare part of Enobio Dx's component NG Geltrode. NG Geltrode is an EEG electrode to be used 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
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
18437017440663PrimaryGS10
08437017440376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843701744066318437017440663
08437017440376084370174403768437017440376

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
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

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 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
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
18436612820269Enobio DxEnobio Dx 82023-09-06

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