BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Neuronaute 1.2 - Head module

    DI: 03615220001774 · Model: 1001-10004-US · BIOSERENITY MEDICAL DEVICES GROUP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Neuronaute 1.2 - Head module
    Primary DI
    03615220001774
    Version / Model
    1001-10004-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
    2021-02-15
    Public Version
    3
    Public Version Date
    2023-12-28
    Public Version Status
    Update
    Public Device Record Key
    44a7aaa0-1966-461f-b37c-d34494979269

    Device Description

    Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.

    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
    GWQ Full-Montage Standard Electroencephalograph

    GMDN Terms

    Code Name
    38736 Electroencephalographic monitoring system

    Identifiers

    Type ID
    Primary 03615220001774

    Premarket Submissions

    Submission Number Supplement Number
    K202334 000