BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Selectra

    DI: 03661540600395 · Model: ProM · VitalScientific B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Selectra
    Primary DI
    03661540600395
    Version / Model
    ProM
    Catalog Number
    6003-435
    Company Name
    VitalScientific B.V.
    Labeler DUNS
    494028946
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-18
    Public Version
    12
    Public Version Date
    2025-05-20
    Public Version Status
    Update
    Public Device Record Key
    b583208b-2c57-4250-abe2-09841dcc03b2
    Distribution End Date
    2025-05-19

    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
    Yes
    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

    GMDN Terms

    Code Name
    56676 Multiple clinical chemistry analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 03661540600395

    Premarket Submissions

    Submission Number Supplement Number
    K102647 000