BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR Buffer Solution

    DI: 06936415904685 · Model: 105-011382-00 · 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
    MR Buffer Solution
    Primary DI
    06936415904685
    Version / Model
    105-011382-00
    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
    2026-01-23
    Public Version
    1
    Public Version Date
    2026-02-02
    Public Version Status
    New
    Public Device Record Key
    c8f976c5-c943-41d4-a716-9ef7aa7f4ce7

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JCB Detergent

    GMDN Terms

    Code Name
    58237 Buffered sample diluent IVD

    Identifiers

    Type ID
    Primary 06936415904685

    Premarket Submissions

    Submission Number Supplement Number
    K160370 000