Neuronaute head S42

Basic Information

• Brand Name: Neuronaute head S42
• Primary DI: 03615220001170
• Version / Model: 1001-01005-US
• Catalog Number: 1001-01005-US
• Company Name: BIOSERENITY MEDICAL DEVICES GROUP
• Labeler DUNS: 281224773
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-22
• Public Version: 3
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: 053d881f-e140-4dad-a5a8-a528131c8777
• Distribution End Date: 2023-11-10

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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

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	03615220001170	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius