BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® Urinary Drainage Bag

    DI: 10704411004097 · 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 Drainage Bag
    Primary DI
    10704411004097
    Version / Model
    1
    Catalog Number
    AS302
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2021-01-08
    Public Version Status
    Update
    Public Device Record Key
    139a0782-6d68-4823-a3ae-8404261b5764

    Device Description

    AMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Double hanger, Sampling adapter, Anti-reflux valve, Protective cap

    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

    GMDN Terms

    Code Name
    58921 Non-wearable adult urine collection bag, open-ended

    Identifiers

    Type ID
    Package 40704411004098
    Primary 10704411004097