BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K ELECTRODE, ISE MODULE

    DI: 05999883586693 · Model: K+ Electrode · Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K ELECTRODE, ISE MODULE
    Primary DI
    05999883586693
    Version / Model
    K+ Electrode
    Catalog Number
    5202
    Company Name
    Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
    Labeler DUNS
    427395277
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-06
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c9ef5ee3-6062-4ded-9369-5d0014614655

    Device Description

    Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CEM Electrode, Ion Specific, Potassium

    GMDN Terms

    Code Name
    59248 Potassium (K+) electrode IVD

    Identifiers

    Type ID
    Primary 05999883586693
    Package 15999883586690

    Customer Contacts

    Phone
    +1207-450-4228
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K101741 000

    Device Sizes

    Type Value Unit Text
    Height 60 Millimeter
    Depth 40 Millimeter
    Width 90 Millimeter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 25 Degrees Celsius