Neuronaute Mobile Application Android

GUDID 03615220004294

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system

• Primary Device ID: 03615220004294
• NIH Device Record Key: 776ae684-40eb-4144-b74a-e82792252e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuronaute Mobile Application Android
• Version Model Number: 5100-00024
• Company DUNS: 281224773
• Company Name: BIOSERENITY MEDICAL DEVICES GROUP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615220004294 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-28
• Device Publish Date: 2024-02-20

Devices Manufactured by BIOSERENITY MEDICAL DEVICES GROUP

• 03615220003679 - Neuronaute Plus Touchproof Extender: 2024-05-30
• 03615220003983 - Neuronaute Plus- Holding Band: 2024-03-29
• 03615220003655 - Neuronaute Plus - DB25 Extender: 2024-02-28
• 03615220003662 - Neuronaute Plus- IceCap Extender: 2024-02-28
• 03615220003990 - Neuronaute Plus - Core Module: 2024-02-28
• 03615220004294 - Neuronaute Mobile Application Android: 2024-02-28
• 03615220004294 - Neuronaute Mobile Application Android: 2024-02-28
• 03615220001026 - Cardioskin Textile S20: 2023-12-28
• 03615220001033 - Cardioskin Textile S22: 2023-12-28