BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lumaflex

    DI: 06970006971038 · Model: ZLD-05 · Shenzhen Kaiyan Medical Equipment Co,. Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lumaflex
    Primary DI
    06970006971038
    Version / Model
    ZLD-05
    Company Name
    Shenzhen Kaiyan Medical Equipment Co,. Ltd
    Labeler DUNS
    543062382
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-12
    Public Version
    1
    Public Version Date
    2023-07-20
    Public Version Status
    New
    Public Device Record Key
    7106c35e-198b-49d0-8875-df17beb1e9bf

    Device Description

    The Lumaflex Panel (Model: ZLD-05) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

    Device Characteristics

    Single Use
    Yes
    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
    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
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    65723 Red/infrared light phototherapy unit

    Identifiers

    Type ID
    Primary 06970006971038