BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Homedics

    DI: 00031262115751 · Model: SPEDOT200HJQ8SH · FKA DISTRIBUTING CO., LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Homedics
    Primary DI
    00031262115751
    Version / Model
    SPEDOT200HJQ8SH
    Company Name
    FKA DISTRIBUTING CO., LLC
    Labeler DUNS
    183280973
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-31
    Public Version
    1
    Public Version Date
    2024-11-08
    Public Version Status
    New
    Public Device Record Key
    97c386bd-cbd4-4e4c-9b64-379ba85c0f86

    Device Description

    ThermaDot

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IRT Pad, Heating, Powered

    GMDN Terms

    Code Name
    64765 Hot/cold therapy system

    Identifiers

    Type ID
    Primary 00031262115751