BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Calibration gas 1

    DI: 05700699621696 · Model: 962-169 · Radiometer Medical ApS
    View on AccessGUDID
    Product Codes
    12
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Calibration gas 1
    Primary DI
    05700699621696
    Version / Model
    962-169
    Catalog Number
    962-169
    Company Name
    Radiometer Medical ApS
    Labeler DUNS
    308667539
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    4
    Public Version Date
    2023-09-28
    Public Version Status
    Update
    Public Device Record Key
    ffbabc24-630f-4dca-98bb-c917dbc5d692
    Distribution End Date
    2023-09-21

    Device Description

    Calibration gas 1, 10bar on-board gas bottle

    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
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    KQI ASSAY, FETAL HEMOGLOBIN
    CIG DIAZO COLORIMETRY, BILIRUBIN
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    KHP ACID, LACTIC, ENZYMATIC METHOD
    CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
    CGA GLUCOSE OXIDASE, GLUCOSE
    GHS ASSAY, CARBOXYHEMOGLOBIN

    GMDN Terms

    Code Name
    52859 Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

    Identifiers

    Type ID
    Primary 05700699621696

    Customer Contacts

    Phone
    +459999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Protect from sunlight. Do not pierce or burn, even after use.
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 50 Degrees Celsius