BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affinity Cable and Leadwire System

    DI: 00850384007085 · Model: 453561432691 · AFFINITY MEDICAL TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affinity Cable and Leadwire System
    Primary DI
    00850384007085
    Version / Model
    453561432691
    Company Name
    AFFINITY MEDICAL TECHNOLOGIES, LLC
    Labeler DUNS
    088091038
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    c4faa562-e30d-4073-b3e6-fe5a418f0961

    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 00850384007085