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    FDA UDI In Commercial Distribution 🇺🇸 United States

    RAPIDPOINT® 350 Sensor Module

    DI: 00630414566337 · Model: 10375812 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    RAPIDPOINT® 350 Sensor Module
    Primary DI
    00630414566337
    Version / Model
    10375812
    Catalog Number
    10375812
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    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
    e1bdb2c0-aaee-4e15-ae0f-5d77e8f1fdd9

    Device Description

    RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    GKF INSTRUMENT, HEMATOCRIT, AUTOMATED

    GMDN Terms

    Code Name
    52866 Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

    Identifiers

    Type ID
    Primary 00630414566337

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K021515 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 25 Degrees Celsius