BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 10190752138186 · Model: 394111-503 · Vyaire Medical Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    10190752138186
    Version / Model
    394111-503
    Catalog Number
    394111-503
    Company Name
    Vyaire Medical Oy
    Labeler DUNS
    368457563
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-13
    Public Version
    1
    Public Version Date
    2019-06-21
    Public Version Status
    New
    Public Device Record Key
    27d77c82-7ce1-4b01-bab3-888536e3d370

    Device Description

    ECG Leadwire Set, 6-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in

    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
    Yes
    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 10190752138186

    Customer Contacts

    Phone
    1-833-327-3284
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -22 – 158 Degrees Fahrenheit