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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Calibration Solution

    DI: 05700699440211 · Model: 944-021 · Radiometer Medical ApS
    View on AccessGUDID
    Product Codes
    11
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Basic Information

    Brand Name
    Calibration Solution
    Primary DI
    05700699440211
    Version / Model
    944-021
    Catalog Number
    944-021
    Company Name
    Radiometer Medical ApS
    Labeler DUNS
    308667539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2020-11-27
    Public Version Status
    Update
    Public Device Record Key
    8a664a0a-11b0-4b37-87a1-ff96b4da1890

    Device Description

    S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX

    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
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    GKF INSTRUMENT, HEMATOCRIT, AUTOMATED
    CGA GLUCOSE OXIDASE, GLUCOSE
    KHP ACID, LACTIC, ENZYMATIC METHOD
    CIG DIAZO COLORIMETRY, BILIRUBIN
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

    GMDN Terms

    Code Name
    35933 Multiple blood gas analyte IVD, calibrator

    Identifiers

    Type ID
    Primary 05700699440211
    Unit of Use 55700699440216

    Customer Contacts

    Phone
    +459999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius