BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GentleCath Hydrophilic Kit

    DI: 07333387044156 · Model: 509012 · Wellspect AB
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    GentleCath Hydrophilic Kit
    Primary DI
    07333387044156
    Version / Model
    509012
    Catalog Number
    509012
    Company Name
    Wellspect AB
    Labeler DUNS
    351118942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-01
    Public Version
    4
    Public Version Date
    2024-11-27
    Public Version Status
    Update
    Public Device Record Key
    25b5a876-9dd7-4e3b-8fb9-33f85894e86f

    Device Description

    Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR

    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
    Yes
    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
    NWO Kit, catheter, urinary (exludes HIV testing)
    EYY Drape, urological, disposable
    FAQ BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
    EZD Catheter, straight
    LYZ Vinyl patient examination glove

    GMDN Terms

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

    Identifiers

    Type ID
    Package 07333387044170
    Package 07333387044163
    Primary 07333387044156
    Previous 00768455142804

    Customer Contacts

    Phone
    +1(800)422-8818
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 16 Inch
    Catheter Gauge 14 French

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry