BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARDIOBLATE®

    DI: 00613994334558 · Model: 4920501 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARDIOBLATE®
    Primary DI
    00613994334558
    Version / Model
    4920501
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-16
    Public Version
    7
    Public Version Date
    2024-02-08
    Public Version Status
    Update
    Public Device Record Key
    a3964b12-0442-4594-9d28-c4ce80242eb3

    Device Description

    ABLATION PEN 4920501 W/PACING SENSING EN

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCL Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

    GMDN Terms

    Code Name
    60784 Cardiac radio-frequency ablation system generator

    Identifiers

    Type ID
    Primary 00613994334558

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    5 – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    – 40 Degrees Celsius