BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BlueSensor NFECG Electrodes

    DI: 05707480026258 · Model: NF-10-A/12 · Ambu A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    12

    Basic Information

    Brand Name
    BlueSensor NFECG Electrodes
    Primary DI
    05707480026258
    Version / Model
    NF-10-A/12
    Catalog Number
    NF-10-A/12
    Company Name
    Ambu A/S
    Labeler DUNS
    305682023
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d73f03e1-4eb5-4951-b1da-9db887280070

    Device Description

    ECG Electrodes Solid Gel A Connector 10 cm Lead Wire

    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
    No
    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 05707480003617
    Package 05707480026241
    Primary 05707480026258
    Unit of Use 05707480026265

    Customer Contacts

    Phone
    +14107686464
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 25 Degrees Celsius