BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PAD 1110C

    DI: 00811331017786 · Model: PAD 1110C · Tz Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PAD 1110C
    Primary DI
    00811331017786
    Version / Model
    PAD 1110C
    Company Name
    Tz Medical, Inc.
    Labeler DUNS
    793149709
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-20
    Public Version
    1
    Public Version Date
    2023-09-28
    Public Version Status
    New
    Public Device Record Key
    05233054-9eaa-4b49-aed8-e441c569b817

    Device Description

    CABLE- DEFIB/PACE/MONITOR

    Device Characteristics

    Single Use
    No
    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
    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
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

    GMDN Terms

    Code Name
    41062 External defibrillation electrode, adult, reusable

    Identifiers

    Type ID
    Primary 00811331017786

    Premarket Submissions

    Submission Number Supplement Number
    K983196 000