BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SimPro™ Set

    DI: 07333387043616 · Model: 5331600 · Wellspect AB
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    SimPro™ Set
    Primary DI
    07333387043616
    Version / Model
    5331600
    Catalog Number
    5331600
    Company Name
    Wellspect AB
    Labeler DUNS
    351118942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-01
    Public Version
    2
    Public Version Date
    2024-11-27
    Public Version Status
    Update
    Public Device Record Key
    00d94514-a142-40d2-b0d5-8addc5794a59

    Device Description

    Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 16FR

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    EYY Drape, urological, disposable
    FAQ BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
    LYZ Vinyl patient examination glove
    NWO Kit, catheter, urinary (exludes HIV testing)
    EZD Catheter, straight

    GMDN Terms

    Code Name
    45605 Single-administration urethral catheterization kit, single-use

    Identifiers

    Type ID
    Package 07333387043623
    Primary 07333387043616
    Package 07333387043630
    Previous 07392532189210

    Customer Contacts

    Phone
    +1(877)456-3742
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 8 Inch
    Catheter Gauge 16 French

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store in a dry place at room temperature.