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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ready Sensor™ GOLD Calcium Sensor

    DI: 00630414510293 · Model: 10315219 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    8
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

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    Basic Information

    Brand Name
    Ready Sensor™ GOLD Calcium Sensor
    Primary DI
    00630414510293
    Version / Model
    10315219
    Catalog Number
    1428622
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2021-11-19
    Public Version Status
    Update
    Public Device Record Key
    ea591ae1-ca82-4f8b-8ef5-2d6508da07f3

    Device Description

    Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments

    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
    CGA GLUCOSE OXIDASE, GLUCOSE
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    KHP ACID, LACTIC, ENZYMATIC METHOD
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    GKR SYSTEM, HEMOGLOBIN, AUTOMATED

    GMDN Terms

    Code Name
    59239 Calcium (Ca2+) electrode IVD

    Identifiers

    Type ID
    Primary 00630414510293
    Unit of Use 00630414010137

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K031560 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight
    Type
    Storage Environment Temperature
    Temperature Range
    4 – 25 Degrees Celsius