BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CueSee® Hyperbaric

    DI: 08718734963035 · Model: 1 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CueSee® Hyperbaric
    Primary DI
    08718734963035
    Version / Model
    1
    Catalog Number
    350.001.005
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-07
    Public Version
    1
    Public Version Date
    2026-01-15
    Public Version Status
    New
    Public Device Record Key
    73be1b32-b334-4da8-9cbd-5633c57834ac

    Device Description

    CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For laboratory and near patient (point-of-care) testing by healthcare professionals.

    Device Characteristics

    Single Use
    Yes
    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
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

    GMDN Terms

    Code Name
    30218 Multiple blood gas analyte IVD, control

    Identifiers

    Type ID
    Package 08718734963042
    Primary 08718734963035