BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes

    DI: 00883873824603 · Model: 11403 · PHYSIO-CONTROL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes
    Primary DI
    00883873824603
    Version / Model
    11403
    Catalog Number
    11403-000001
    Company Name
    PHYSIO-CONTROL, INC.
    Labeler DUNS
    009251992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-20
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    efb87930-fd56-4262-9a29-7fdb16b959c3

    Device Description

    SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    MKJ Automated external defibrillators (non-wearable)

    GMDN Terms

    Code Name
    44771 External defibrillation electrode, adult, single-use

    Identifiers

    Type ID
    Primary 00883873824603

    Premarket Submissions

    Submission Number Supplement Number
    P160012 002
    P160012 005