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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hepatus 6 Diagnostic Ultrasound System

    DI: 06936415975081 · Model: Hepatus 6 · 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
    Hepatus 6 Diagnostic Ultrasound System
    Primary DI
    06936415975081
    Version / Model
    Hepatus 6
    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
    2025-02-17
    Public Version
    2
    Public Version Date
    2026-01-09
    Public Version Status
    Update
    Public Device Record Key
    5463385f-533c-47bf-a0cb-839cf4e36f1b

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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 06936415975081

    Premarket Submissions

    Submission Number Supplement Number
    K200643 000
    K251601 000