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    FDA UDI In Commercial Distribution 🇺🇸 United States

    M7 PEM(FDA,PEM-21,For UMT-200)

    DI: 06944904089768 · Model: 115-009386-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    M7 PEM(FDA,PEM-21,For UMT-200)
    Primary DI
    06944904089768
    Version / Model
    115-009386-00
    Company Name
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    Labeler DUNS
    654671304
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c3f40c05-afbd-4c26-ba4c-fc4ab8d30286

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYN System, imaging, pulsed doppler, ultrasonic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06944904089768

    Customer Contacts

    Phone
    +8675581888998
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K131690 000