Neuronaute 1.2 - BioAdapter

Basic Information

• Brand Name: Neuronaute 1.2 - BioAdapter
• Primary DI: 03615220001781
• Version / Model: 1001-15015-US
• Company Name: BIOSERENITY MEDICAL DEVICES GROUP
• Labeler DUNS: 281224773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-12
• Public Version: 2
• Public Version Date: 2023-12-28
• Public Version Status: Update
• Public Device Record Key: fc6e8520-31c6-4584-ae24-9c0668bd0698

Device Description

It enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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

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	03615220001781	GS1

Premarket Submissions

Submission Number	Supplement Number
K202334	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal