BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LITTLEmack

    DI: 00850011150078 · Model: 10000042 · Ablenet, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LITTLEmack
    Primary DI
    00850011150078
    Version / Model
    10000042
    Catalog Number
    10000042
    Company Name
    Ablenet, Inc.
    Labeler DUNS
    791664543
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    1
    Public Version Date
    2023-06-29
    Public Version Status
    New
    Public Device Record Key
    dfec5ee8-8627-4820-8225-162f0746d021

    Device Description

    Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet 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 00850011150078