BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ambu WhiteSensor

    DI: 08906035282881 · Model: 4500M · MEDICO ELECTRODES INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    30

    Basic Information

    Brand Name
    Ambu WhiteSensor
    Primary DI
    08906035282881
    Version / Model
    4500M
    Company Name
    MEDICO ELECTRODES INTERNATIONAL LIMITED
    Labeler DUNS
    677425215
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    30
    Record Status
    Published
    Publish Date
    2020-08-20
    Public Version
    1
    Public Version Date
    2020-08-28
    Public Version Status
    New
    Public Device Record Key
    e0fae5b1-74c7-4d6d-8bdb-5f9f62434230

    Device Description

    Electrocardiographic electrode, single use

    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 Conditional
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    DRX Electrode, Electrocardiograph

    GMDN Terms

    Code Name
    35035 Electrocardiographic electrode, single-use

    Identifiers

    Type ID
    Package 18906035282888
    Primary 08906035282881
    Package 28906035282885
    Unit of Use 48906035282889

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    41 – 86 Degrees Fahrenheit