BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® Add-A-Foley Catheter Tray

    DI: 10704411007241 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMSure® Add-A-Foley Catheter Tray
    Primary DI
    10704411007241
    Version / Model
    1
    Catalog Number
    AS89330
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-30
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    f22e4fc0-a46a-488b-98d5-8c27d0b4ee96

    Device Description

    AMSure® Add-A-Foley Catheter Tray CONTENTS: One each 2000 mL Drainage bag with: Large anti-reflux chamber Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe needleless sampling port

    Device Characteristics

    Single Use
    Yes
    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    GMDN Terms

    Code Name
    47778 Intermittent urethral catheterization kit

    Identifiers

    Type ID
    Package 40704411007242
    Primary 10704411007241