BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

    Reg #: 3011823740 · FEI: 3011823740 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Greatbatch Medical S. de R.L. de C.V.
    Registration Number
    3011823740
    FEI Number
    3011823740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle 5 Norte No. 511 Ciudad Industrial
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K021453

    Owner / Operator

    Firm Name
    GREATBATCH MEDICAL
    Operator Number
    9035261
    Address
    2300 Berkshire Lane N, --
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US

    US Agent

    Business Name
    Director Quality and Regulatory Affairs
    Contact Name
    Maria Mundaden
    Address
    2300 Berkshire Ln N
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US
    Email
    [email protected]
    Phone
    763 9518200

    Products

    Device Name Product Code
    Automated External Defibrillators (Non-Wearable) MKJ
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD

    Proprietary Names

    HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)