BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    S5362 REF 943-906

    DI: 05700699439062 · Model: 943-906 · Radiometer Medical ApS
    View on AccessGUDID
    Product Codes
    12
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    S5362 REF 943-906
    Primary DI
    05700699439062
    Version / Model
    943-906
    Catalog Number
    943-906
    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
    57716c29-4fd3-46e4-ae75-5045f6a96210

    Device Description

    S5362 Hypochlorit Solution for protein Removal and decontamination 100mL for BPH5, ABL5/50/5XX, EML10X ABL8XX

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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 05700699439062

    Customer Contacts

    Phone
    +45999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight