BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CARELINK® MONITOR

    DI: 00643169341067 · Model: 2490G23 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARELINK® MONITOR
    Primary DI
    00643169341067
    Version / Model
    2490G23
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    4
    Public Version Date
    2018-12-21
    Public Version Status
    Update
    Public Device Record Key
    1cdcdc62-fcc2-4654-aa06-239689cb5e79
    Distribution End Date
    2018-11-09

    Device Description

    MON 2490G23 CARELINK MR5 USA RFB

    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
    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
    OSR Pacemaker/icd/crt non-implanted components

    GMDN Terms

    Code Name
    61438 Cardiac pulse generator reader, home-use

    Identifiers

    Type ID
    Primary 00643169341067

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P890003 284

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 150 Degrees Fahrenheit