BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CueSee® Hyperbaric X-High

    DI: 08718734961093 · Model: 164.002.004 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CueSee® Hyperbaric X-High
    Primary DI
    08718734961093
    Version / Model
    164.002.004
    Catalog Number
    164.002.004
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-08
    Public Version
    1
    Public Version Date
    2021-06-16
    Public Version Status
    New
    Public Device Record Key
    78e02d51-1e96-493b-a79d-d7a117cb66c2

    Device Description

    CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers.

    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
    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

    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 08718734961109
    Primary 08718734961093

    Premarket Submissions

    Submission Number Supplement Number
    K955340 000