BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: 00304040001424 · Model: 1127164 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Henry Schein
    Primary DI
    00304040001424
    Version / Model
    1127164
    Catalog Number
    1127164
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-02-20
    Public Version Status
    Update
    Public Device Record Key
    2405ce0f-f0c9-453e-abad-1a8a81a56793

    Device Description

    Pad Defib Ped Zoll

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LDD Dc-defibrillator, low-energy, (including paddles)

    GMDN Terms

    Code Name
    11130 Electrode conductive skin pad, single-use

    Identifiers

    Type ID
    Package 10304040001421
    Primary 00304040001424

    Premarket Submissions

    Submission Number Supplement Number
    K081442 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 40 Degrees Celsius