BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioHermes Blood Glucose Control Solution

    DI: 06935784450106 · Model: GLU-GE C01 · Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioHermes Blood Glucose Control Solution
    Primary DI
    06935784450106
    Version / Model
    GLU-GE C01
    Catalog Number
    GLU-C12
    Company Name
    Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
    Labeler DUNS
    528192913
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-10
    Public Version
    1
    Public Version Date
    2024-01-18
    Public Version Status
    New
    Public Device Record Key
    1ade8dcf-f0f3-4eea-ae0f-bfb3ce584310

    Device Description

    Blood Glucose Control Solution Intended use: The blood glucose control solution is intended to be used with corresponding blood glucose test strips and blood glucose meter as well as blood glucose and glycohemoglobin analyzer manufactured by Wuxi BioHermes Bio&Medical Technology Co., Ltd. Contents: 1x2mL Control L, 1x2mL Control N, 1x2mL Control H.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 06935784450106