BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    U-Bag Urine Collector

    DI: 00840113231744 · Model: 7537 · ASPEN SURGICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    U-Bag Urine Collector
    Primary DI
    00840113231744
    Version / Model
    7537
    Company Name
    ASPEN SURGICAL PRODUCTS, INC.
    Labeler DUNS
    027680821
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-27
    Public Version
    1
    Public Version Date
    2023-03-07
    Public Version Status
    New
    Public Device Record Key
    bc1b338f-9945-42c1-a4be-03d6c93136a6

    Device Description

    Stork U-Bag, Urine Collection Bag, 100mL, Newborn, 24 Hour Specimen, Cloth Adhesive, Sterile, 1/pouch, 50 pouches/box

    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
    Yes
    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
    58930 Adhesive paediatric urine collection bag, closed-ended

    Identifiers

    Type ID
    Primary 00840113231744