BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    My-TECH

    DI: 00021292013097 · Model: My-TECH Ring Self Monitoring Blood Glucose Meter · TRIVIDIA HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    My-TECH
    Primary DI
    00021292013097
    Version / Model
    My-TECH Ring Self Monitoring Blood Glucose Meter
    Catalog Number
    TF4H01-00
    Company Name
    TRIVIDIA HEALTH, INC.
    Labeler DUNS
    151810868
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-08
    Public Version
    3
    Public Version Date
    2025-06-09
    Public Version Status
    Update
    Public Device Record Key
    e259d8ce-41db-4aa5-b669-ff50fd147c99

    Device Description

    My-TECH Ring Self Monitoring Blood Glucose Meter

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    Yes
    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
    LFR Glucose Dehydrogenase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Direct Marking 00021292012991
    Package 10021292013094
    Primary 00021292013097

    Customer Contacts

    Phone
    +1(800)803-6025
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    40 – 86 Degrees Fahrenheit