BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    M-53LH LYSE

    DI: 06944904093161 · Model: M-53LH · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    M-53LH LYSE
    Primary DI
    06944904093161
    Version / Model
    M-53LH
    Catalog Number
    105-011735-00
    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
    2026-01-22
    Public Version
    1
    Public Version Date
    2026-01-30
    Public Version Status
    New
    Public Device Record Key
    666cbab4-931f-43f3-94a6-e188095c1ef7

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GGK Products, Red-Cell Lysing Products

    GMDN Terms

    Code Name
    61165 Blood cell lysis reagent IVD

    Identifiers

    Type ID
    Primary 06944904093161