BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient Leadwire

    DI: 90817266020122 · Model: 20900-X-5A · MERIT CABLES INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Patient Leadwire
    Primary DI
    90817266020122
    Version / Model
    20900-X-5A
    Company Name
    MERIT CABLES INCORPORATED
    Labeler DUNS
    180587883
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2022-01-03
    Public Version Status
    Update
    Public Device Record Key
    9cc9ed4b-c7b8-45f0-ae78-5baabffbb34b

    Device Description

    5 Lead Set IEC Color Scheme (R, Grn, Yel, Blk, Wht)

    Device Characteristics

    Single Use
    No
    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 Unsafe
    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 90817266020122

    Customer Contacts

    Phone
    714-918-1935
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K942321 000

    Device Sizes

    Type Value Unit Text
    Length 120 Inch
    Length 60 Inch
    Length 40 Inch
    Length 24 Inch
    Length 18 Inch
    Length 14 Inch