BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® Urinary Leg Bag

    DI: 10704411008255 · 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® Urinary Leg Bag
    Primary DI
    10704411008255
    Version / Model
    1
    Catalog Number
    AS308F
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-30
    Public Version
    4
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    4e9b4f58-07a6-40ad-94c9-e73248741da3

    Device Description

    AMSure® Urinary Leg Bag Medium - 600 mL, Flip valve CONTENTS: One each 600 mL Urinary Leg Bag equipped with: Flip valve drainage bag, Anti-reflux Valve, Two Latex-Free Straps

    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
    Yes
    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
    FAQ Bag, Urine Collection, Leg, For External Use, Sterile

    GMDN Terms

    Code Name
    58923 Wearable adult urine collection bag, open-ended

    Identifiers

    Type ID
    Package 40704411008256
    Primary 10704411008255