BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UltraFlo Insulin Pen Needle

    DI: B7443357721 · Model: 335772 · QUALITY MEDICAL PRODUCTS USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    100

    Basic Information

    Brand Name
    UltraFlo Insulin Pen Needle
    Primary DI
    B7443357721
    Version / Model
    335772
    Company Name
    QUALITY MEDICAL PRODUCTS USA, INC.
    Labeler DUNS
    054180248
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2019-06-24
    Public Version
    2
    Public Version Date
    2020-01-20
    Public Version Status
    Update
    Public Device Record Key
    d685c8f5-4a58-4cd5-aae3-d5b9cc109c98

    Device Description

    31G X 3/16" (5mm)

    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

    GMDN Terms

    Code Name
    44127 Autoinjector needle

    Identifiers

    Type ID
    Package B7443357723
    Package B7443357722
    Primary B7443357721
    Unit of Use B7443357720