BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CL ELECTRODE, ISE MODULE

    DI: 05999883586709 · Model: Cl- 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
    CL ELECTRODE, ISE MODULE
    Primary DI
    05999883586709
    Version / Model
    Cl- Electrode
    Catalog Number
    5203
    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
    0da47eb8-8c23-4978-b5d5-35268ac662fb

    Device Description

    Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    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
    CGZ Electrode, Ion-Specific, Chloride

    GMDN Terms

    Code Name
    59240 Chloride (Cl-) electrode IVD

    Identifiers

    Type ID
    Package 15999883586706
    Primary 05999883586709

    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