Enobio Dx

Basic Information

• Brand Name: Enobio Dx
• Primary DI: 18436612823000
• Version / Model: Neoprene Headcap (Kit, size M) - Component Replacement: Enobio Dx
• Company Name: NEUROELECTRICS BARCELONA SL
• Labeler DUNS: 463756944
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-13
• Public Version: 1
• Public Version Date: 2023-09-21
• Public Version Status: New
• Public Device Record Key: 75ad0329-ac2b-424d-afb9-0745b80898c2

Device Description

This device is the replacement of Enobio Dx's component Neoprene Headcap (size M, kit). 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
GWL	Amplifier, Physiological Signal	Neurology	882.1835	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38736	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18436612823000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162681	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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.