BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ready Sensor™ GOLD Calcium Sensor

    DI: 00630414112169 · Model: 10315922 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Ready Sensor™ GOLD Calcium Sensor
    Primary DI
    00630414112169
    Version / Model
    10315922
    Catalog Number
    476268
    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
    6aebb711-d8d5-40de-be30-308a9c873c65

    Device Description

    Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 348/348ex 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
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

    GMDN Terms

    Code Name
    52874 Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)

    Identifiers

    Type ID
    Primary 00630414112169
    Unit of Use 00630414010144

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K934907 000

    Storage Conditions

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