BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CueSee® CO-OX

    DI: 08718734961598 · Model: S5B · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CueSee® CO-OX
    Primary DI
    08718734961598
    Version / Model
    S5B
    Catalog Number
    AN01718A03
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-19
    Public Version
    1
    Public Version Date
    2021-12-27
    Public Version Status
    New
    Public Device Record Key
    6d8009c7-7c21-4b48-9ca6-8d4f037c0bfb

    Device Description

    CueSee® CO-OX S5B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GGM Control, Hemoglobin

    GMDN Terms

    Code Name
    55878 Multiple haemoglobin subtype IVD, control

    Identifiers

    Type ID
    Package 08718734961628
    Primary 08718734961598