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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cleaning Solution with additive S8375 REF 944-126

    DI: 05700699441263 · Model: 944-126 · Radiometer Medical ApS
    View on AccessGUDID
    Product Codes
    12
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cleaning Solution with additive S8375 REF 944-126
    Primary DI
    05700699441263
    Version / Model
    944-126
    Catalog Number
    944-126
    Company Name
    Radiometer Medical ApS
    Labeler DUNS
    308667539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-21
    Public Version
    1
    Public Version Date
    2018-10-22
    Public Version Status
    New
    Public Device Record Key
    f98224c8-4caa-40a1-938e-910427e0f72a

    Device Description

    S8375 Cleaning Solution 175mL for ABL8XX

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KHP ACID, LACTIC, ENZYMATIC METHOD
    CGA GLUCOSE OXIDASE, GLUCOSE
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
    MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    CIG DIAZO COLORIMETRY, BILIRUBIN
    CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
    GHS ASSAY, CARBOXYHEMOGLOBIN
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    KQI ASSAY, FETAL HEMOGLOBIN
    JGS ELECTRODE, ION SPECIFIC, SODIUM

    GMDN Terms

    Code Name
    59058 Wash/cleaning solution IVD, automated/semi-automated system

    Identifiers

    Type ID
    Primary 05700699441263

    Customer Contacts

    Phone
    +45999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Single use
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius