Neuronaute Touchproof Adapter

Basic Information

• Brand Name: Neuronaute Touchproof Adapter
• Primary DI: 03615220004171
• Version / Model: 1001-15024-US
• Catalog Number: 1001-15024-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: 2023-04-24
• Public Version: 3
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: a7fc6f3f-1c67-4855-99f6-c542723a7897

Device Description

The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to Neuronaute BioAdapter through the touchproof connection.

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: 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17554	Electroencephalographic electrode cap, single-use	An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615220004171	GS1

Premarket Submissions

Submission Number	Supplement Number
K202334	000
K223644	000

Storage Conditions

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