BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HeartStart

    DI: 10884838002859 · Model: Heartstart Pads · PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    HeartStart
    Primary DI
    10884838002859
    Version / Model
    Heartstart Pads
    Catalog Number
    M3716A
    Company Name
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Labeler DUNS
    079503890
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-02-25
    Public Version
    3
    Public Version Date
    2023-09-20
    Public Version Status
    Update
    Public Device Record Key
    e11cfc40-1d59-4cd8-989e-f85b53540ee2
    Distribution End Date
    2022-04-08

    Device Description

    HS Adult/Child Radiolucent Pads

    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
    MKJ Automated external defibrillators (non-wearable)

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use 00884838111493
    Primary 10884838002859

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 95 Degrees Fahrenheit