BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIO-DETEK MFE

    DI: 00847946018405 · Model: AD-2038-0001 · Zoll Medical Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIO-DETEK MFE
    Primary DI
    00847946018405
    Version / Model
    AD-2038-0001
    Company Name
    Zoll Medical Corporation
    Labeler DUNS
    055363428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    3
    Public Version Date
    2022-02-08
    Public Version Status
    Update
    Public Device Record Key
    52f71565-2ccf-4acb-8bdb-4f1cb3746f75

    Device Description

    ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE PHYSIO CON - SINGLE

    Device Characteristics

    Single Use
    Yes
    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
    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
    48048 Rechargeable professional automated external defibrillator

    Identifiers

    Type ID
    Primary 00847946018405
    Package 10847946018402