BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FLEXI-SEAL

    DI: 00768455107902 · Model: 411101 · CONVATEC, PURCHASING DEPARTMENT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    FLEXI-SEAL
    Primary DI
    00768455107902
    Version / Model
    411101
    Company Name
    CONVATEC, PURCHASING DEPARTMENT
    Labeler DUNS
    809784593
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2019-04-19
    Public Version
    4
    Public Version Date
    2022-10-11
    Public Version Status
    Update
    Public Device Record Key
    5407f50f-960b-47f0-be13-b5557e28ed06
    Distribution End Date
    2022-05-20

    Device Description

    Flexi-Seal FMS Collection Bags

    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
    No
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EZQ Pouch, Colostomy

    GMDN Terms

    Code Name
    47038 Faecal incontinence collector, catheterization

    Identifiers

    Type ID
    Package 10768455107909
    Primary 00768455107902
    Unit of Use 80768455107908

    Customer Contacts

    Phone
    1-800-422-8811
    Email
    [email protected]