BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZENIX

    DI: 00198843000360 · Model: 1116-211047-21-USA-0 · Zoll Medical Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZENIX
    Primary DI
    00198843000360
    Version / Model
    1116-211047-21-USA-0
    Company Name
    Zoll Medical Corporation
    Labeler DUNS
    055363428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-01
    Public Version
    2
    Public Version Date
    2026-01-28
    Public Version Status
    Update
    Public Device Record Key
    e3d39094-8a01-4302-a270-9da92ed4f8ee

    Device Description

    ZENIX, HOSPITAL FULLY LOADED CONFIGURATION WITH MNC

    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
    MR Unsafe
    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
    MKJ Automated External Defibrillators (Non-Wearable)

    GMDN Terms

    Code Name
    48048 Rechargeable professional automated external defibrillator

    Identifiers

    Type ID
    Primary 00198843000360