BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CueSee VeriSTAT®

    DI: 08718734962533 · Model: S2 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CueSee VeriSTAT®
    Primary DI
    08718734962533
    Version / Model
    S2
    Catalog Number
    AN01902A02
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-29
    Public Version
    1
    Public Version Date
    2024-11-06
    Public Version Status
    New
    Public Device Record Key
    12522053-4c5f-4cae-8927-ad8b9d70ee2a

    Device Description

    CueSee VeriSTAT® S2 is an unassayed quality control material for professional use to verify the performance characteristics of the Abbott i-STAT® system analyzer. The device is intended for the quantitative determination of blood gases (pH, pO2, pCO2), electrolytes (Na+, K+, Ca2+, Cl-), metabolites (glucose, lactate, creatinine, urea), tCO2 and hematocrit.

    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
    OHQ Multi-Analyte Controls Unassayed

    GMDN Terms

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

    Identifiers

    Type ID
    Package 08718734962618
    Primary 08718734962533