BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quick-20m

    DI: 00860009903715 · Model: SYS-0001-D · CGX, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Quick-20m
    Primary DI
    00860009903715
    Version / Model
    SYS-0001-D
    Catalog Number
    SYS-0001-D
    Company Name
    CGX, LLC
    Labeler DUNS
    117158699
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-29
    Public Version
    1
    Public Version Date
    2025-10-07
    Public Version Status
    New
    Public Device Record Key
    80f80a86-ddf9-4e4d-b3e4-5a8fa3ce43a6

    Device Description

    The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWL Amplifier, Physiological Signal
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    32521 Multiple physiological signal amplifier

    Identifiers

    Type ID
    Primary 00860009903715

    Customer Contacts

    Phone
    8588649400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K203331 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    40 – 104 Degrees Fahrenheit