Enobio Dx

GUDID 18436612823031

This device is the spare part of Enobio Dx's component Neoprene Headcap (size L). 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.

NEUROELECTRICS BARCELONA SL

Electroencephalographic monitoring system
Primary Device ID18436612823031
NIH Device Record Key05b41537-b34a-46bf-922f-5cefd5d1f68a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnobio Dx
Version Model NumberNeoprene Headcap (size L) - Component Spare Part:
Company DUNS463756944
Company NameNEUROELECTRICS BARCELONA SL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com
Phone+34 932540366
Emailsupport@neuroelectrics.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.
Special Storage Condition, SpecifyBetween 0 and 0 *Wash 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.

Device Identifiers

Device Issuing AgencyDevice ID
GS118436612823031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

On-Brand Devices [Enobio Dx]

18436612820283Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
18436612820276Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
18436612820269Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the re
18436612823024This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size KS). It is use
18436612823017This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size K). It is used
18436612823000This device is the replacement of Enobio Dx's component Neoprene Headcap (size M, kit). It is us
08437017440406This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode
18437017440670This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode
08437017440376This device is the spare part of Enobio Dx's component NG Geltrode. NG Geltrode is an EEG electr
18437017440656This device is the spare part of Enobio Dx's component NG Geltrode. NG Geltrode is an EEG electr
08437017440383This device is the spare part of Enobio Dx's component Foretrode. Foretrode is an EEG electrode
18437017440625This device is the replacement of Enobio Dx's component Earclip. Foretrode is an EEG electrode t
18437017440618This device is the replacement of Enobio Dx's component Earclip. Earclip is the electrical refer
08437017440390This device is the spare part of Enobio Dx's component Drytrode. Drytrode is a dry electrode int
18436612823079This device is the spare part of Enobio Dx's component Neoprene Headband. It is used to precisel
18436612823062This device is the spare part of Enobio Dx's component Neoprene Headcap (size XL). It is used to
18436612823055This device is the spare part of Enobio Dx's component Neoprene Headcap (size S). It is used to
18436612823048This device is the spare part of Enobio Dx's component Neoprene Headcap (size M). It is used to
18436612823031This device is the spare part of Enobio Dx's component Neoprene Headcap (size L). It is used to
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