BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ECG Lead Wires

    DI: 00816396021730 · Model: 590448 · IVY BIOMEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ECG Lead Wires
    Primary DI
    00816396021730
    Version / Model
    590448
    Catalog Number
    590448
    Company Name
    IVY BIOMEDICAL SYSTEMS, INC.
    Labeler DUNS
    109132019
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2022-01-03
    Public Version Status
    Update
    Public Device Record Key
    78adc463-a2b8-4320-a687-9aec0f478a92

    Device Description

    ECG Lead Wires, Metallic, 4 Lead Set, IEC, 30 in

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

    GMDN Terms

    Code Name
    35562 Electrocardiographic lead set, reusable

    Identifiers

    Type ID
    Primary 00816396021730

    Customer Contacts

    Phone
    203-481-4183
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K942321 000

    Device Sizes

    Type Value Unit Text
    Length 30 Inch