BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: 00304040001448 · Model: 1127163 · 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
    00304040001448
    Version / Model
    1127163
    Catalog Number
    1127163
    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
    791de5e2-2ef7-4231-ba2f-637f3dd4bf7a

    Device Description

    Pad Defib Physio T100AC

    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
    MLN Electrode, electrodcardiograph, multi-function

    GMDN Terms

    Code Name
    11130 Electrode conductive skin pad, single-use

    Identifiers

    Type ID
    Package 10304040001445
    Primary 00304040001448

    Premarket Submissions

    Submission Number Supplement Number
    K080421 000

    Storage Conditions

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