BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medtronic CareLink® Programmer

    DI: 00613994175397 · Model: 2090 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medtronic CareLink® Programmer
    Primary DI
    00613994175397
    Version / Model
    2090
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    4
    Public Version Date
    2023-07-25
    Public Version Status
    Update
    Public Device Record Key
    614fa889-1da8-414e-b49b-184f501565f9

    Device Description

    PROG 2090 TEL C US EN UPGRADE SW JUN06

    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
    KRG Programmer, pacemaker

    GMDN Terms

    Code Name
    47205 Cardiac pulse generator programmer

    Identifiers

    Type ID
    Primary 00613994175397

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P890003 065

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -7.6 – 140 Degrees Fahrenheit