BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Urinary Leg Bag

    DI: 06974500612565 · Model: JH02B02 · GCMEDICA ENTERPRISE LTD.(WUXI)
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Urinary Leg Bag
    Primary DI
    06974500612565
    Version / Model
    JH02B02
    Company Name
    GCMEDICA ENTERPRISE LTD.(WUXI)
    Labeler DUNS
    560122957
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-07
    Public Version
    2
    Public Version Date
    2025-10-10
    Public Version Status
    Update
    Public Device Record Key
    b1caff16-fb16-4ca0-a783-fa0918c31d63

    Device Description

    700 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    58917 Non-wearable adult urine collection bag, closed-ended

    Identifiers

    Type ID
    Package 16974500612562
    Primary 06974500612565