BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CueSee® BGEM

    DI: 08718734962960 · Model: 3 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CueSee® BGEM
    Primary DI
    08718734962960
    Version / Model
    3
    Catalog Number
    344.003.005
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-25
    Public Version
    1
    Public Version Date
    2025-08-04
    Public Version Status
    New
    Public Device Record Key
    bede0c41-f176-4544-91e2-d97b298f416d

    Device Description

    CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, glucose, lactate, urea and creatinine measurements on blood gas, electrolytes and metabolite analyzers. For laboratory and near-patient (point-of-care) testing by healthcare professionals.

    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
    Labeling does not contain MRI Safety Information
    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
    OHQ Multi-Analyte Controls Unassayed

    GMDN Terms

    Code Name
    52860 Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

    Identifiers

    Type ID
    Package 08718734963011
    Primary 08718734962960