BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Urinary Drainage Bag

    DI: 06974500612589 · Model: JH01B01 · 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 Drainage Bag
    Primary DI
    06974500612589
    Version / Model
    JH01B01
    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
    968217f3-e589-4abf-91ff-8bc1518a7476

    Device Description

    2000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap

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

    GMDN Terms

    Code Name
    58917 Non-wearable adult urine collection bag, closed-ended

    Identifiers

    Type ID
    Package 16974500612586
    Primary 06974500612589