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    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEPRO.US - Needle Pen Tip Case

    DI: 00854427007940 · Model: CT - Insulin Pen Needles · HEPRO.US INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5000

    Basic Information

    Brand Name
    HEPRO.US - Needle Pen Tip Case
    Primary DI
    00854427007940
    Version / Model
    CT - Insulin Pen Needles
    Company Name
    HEPRO.US INC.
    Labeler DUNS
    080061451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5000
    Record Status
    Published
    Publish Date
    2017-06-21
    Public Version
    4
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    06814811-5cb7-465d-a05f-9fb932fac429

    Device Description

    Insulin Pen Needle Sterile Single Use Pen Needle 5,000 pcs per case

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMI Needle, Hypodermic, Single Lumen

    GMDN Terms

    Code Name
    59230 Hypodermic needle, single-use

    Identifiers

    Type ID
    Primary 00854427007940
    Unit of Use 85442700794002