BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ambu WhiteSensor

    DI: 08906035281587 · Model: 4500M-H/3 · MEDICO ELECTRODES INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    3

    Basic Information

    Brand Name
    Ambu WhiteSensor
    Primary DI
    08906035281587
    Version / Model
    4500M-H/3
    Company Name
    MEDICO ELECTRODES INTERNATIONAL LIMITED
    Labeler DUNS
    677425215
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    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
    849cc6d2-7c28-48e5-86c8-e748485b963b

    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
    Labeling does not contain MRI Safety Information
    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 18906035281584
    Primary 08906035281587
    Package 28906035281581
    Unit of Use 48906035281585

    Storage Conditions

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