BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QuickTalker Freestyle Mini

    DI: 00850011150290 · Model: 70000119 · Ablenet, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QuickTalker Freestyle Mini
    Primary DI
    00850011150290
    Version / Model
    70000119
    Catalog Number
    70000119
    Company Name
    Ablenet, Inc.
    Labeler DUNS
    791664543
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-23
    Public Version
    1
    Public Version Date
    2023-07-03
    Public Version Status
    New
    Public Device Record Key
    1562a1cf-1489-4ab2-a38a-dd851fc0031f

    Device Description

    The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to communicate with others. Individuals with Autism, physical or cognitive impairments that prevent clear speech and individuals who are non-verbal have all benefited from using a QuickTalker Freestyle speech device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    ILQ System, Communication, Powered

    GMDN Terms

    Code Name
    65767 Assistive speech generator

    Identifiers

    Type ID
    Primary 00850011150290