BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    agelh

    DI: 06973826010017 · Model: BT-302 · DONGGUAN E-TEST TECHNOLOGY CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    agelh
    Primary DI
    06973826010017
    Version / Model
    BT-302
    Company Name
    DONGGUAN E-TEST TECHNOLOGY CO.,LTD
    Labeler DUNS
    554511666
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-18
    Public Version
    2
    Public Version Date
    2021-02-22
    Public Version Status
    Update
    Public Device Record Key
    7e72f3fa-383c-4d34-9430-9b8ab20e3a40

    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
    No
    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
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    14035 Intermittent electronic patient thermometer

    Identifiers

    Type ID
    Primary 06973826010017
    Package 16973826010014

    Premarket Submissions

    Submission Number Supplement Number
    K193621 000