BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AED Battery Exchange

    DI: 00864312000284 · Model: G5-ABE · AED BATTERY EXCHANGE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AED Battery Exchange
    Primary DI
    00864312000284
    Version / Model
    G5-ABE
    Company Name
    AED BATTERY EXCHANGE, LLC
    Labeler DUNS
    039840984
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-25
    Public Version
    1
    Public Version Date
    2021-03-05
    Public Version Status
    New
    Public Device Record Key
    840a07bd-bd42-4c05-b0a6-d1046c777203

    Device Description

    Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    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
    48058 Disposable battery pack

    Identifiers

    Type ID
    Primary 00864312000284

    Premarket Submissions

    Submission Number Supplement Number
    P190013 000