AccessGUDID - DEVICE: Neuronaute 1.2 - BioAdapter (03615220001781)

GUDID

Device Identifier (DI) Information

Brand Name: Neuronaute 1.2 - BioAdapter
Version or Model: 1001-15015-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOSERENITY MEDICAL DEVICES GROUP

Primary DI Number: 03615220001781
Issuing Agency: GS1
Commercial Distribution End Date: January 21, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 281224773 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

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Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202334	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc6e8520-31c6-4584-ae24-9c0668bd0698
Public Version Date: January 23, 2025
Public Version Number: 4
DI Record Publish Date: January 12, 2023