BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AMC&E

    DI: 10817357020486 · Model: LW-309DS50/5A · HYGIA HEALTH SERVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMC&E
    Primary DI
    10817357020486
    Version / Model
    LW-309DS50/5A
    Company Name
    HYGIA HEALTH SERVICES, INC.
    Labeler DUNS
    177939027
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    3
    Public Version Date
    2021-03-19
    Public Version Status
    Update
    Public Device Record Key
    cfe311b6-3d52-4793-a54e-add4d1365ecd
    Distribution End Date
    2019-05-10

    Device Description

    AMC&E 5-lead DIN to Pinch Leadset

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    IKD Cable, Electrode

    GMDN Terms

    Code Name
    61812 Electrocardiographic lead set, reprocessed

    Identifiers

    Type ID
    Package 30817357020480
    Primary 10817357020486