BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Unistik VacuFlip

    DI: 00384707101018 · Model: BC 7101 · OWEN MUMFORD USA INCORPORATED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Unistik VacuFlip
    Primary DI
    00384707101018
    Version / Model
    BC 7101
    Company Name
    OWEN MUMFORD USA INCORPORATED
    Labeler DUNS
    803401454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2023-09-22
    Public Version
    1
    Public Version Date
    2023-10-02
    Public Version Status
    New
    Public Device Record Key
    9fccd438-2a5c-4dec-815c-1b5891731f36

    Device Description

    Unistik VacuFlip, 21G safety needle 1"

    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
    No
    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
    FMI Needle, Hypodermic, Single Lumen
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

    GMDN Terms

    Code Name
    58497 Blood collection set, invasive

    Identifiers

    Type ID
    Package 00384707101032
    Primary 00384707101018
    Unit of Use 00384707101001

    Premarket Submissions

    Submission Number Supplement Number
    K223854 000