BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Defibrillation Electrodes

    DI: 10811331010692 · Model: P-311-Z1 · Tz Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Defibrillation Electrodes
    Primary DI
    10811331010692
    Version / Model
    P-311-Z1
    Company Name
    Tz Medical, Inc.
    Labeler DUNS
    793149709
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-12-30
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    96dd5873-bec5-4d1f-a1c6-f96b94371b71

    Device Description

    LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

    GMDN Terms

    Code Name
    11130 Electrode conductive skin pad, single-use

    Identifiers

    Type ID
    Unit of Use 00811331010695
    Primary 10811331010692