BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRUEplus

    DI: 00021292005887 · Model: TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulin · TRIVIDIA HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    20
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    TRUEplus
    Primary DI
    00021292005887
    Version / Model
    TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulin
    Company Name
    TRIVIDIA HEALTH, INC.
    Labeler DUNS
    151810868
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    6
    Public Version Date
    2024-08-30
    Public Version Status
    Update
    Public Device Record Key
    7a5cb596-7610-41f6-98d7-6a2220d2e007

    Device Description

    TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulin

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMF Syringe, Piston

    GMDN Terms

    Code Name
    38501 Insulin syringe/needle, basic

    Identifiers

    Type ID
    Primary 00021292005887
    Unit of Use 00021292008062
    Package 00096295125429
    Package 50096295125424
    Package 00021292005054
    Package 10021292005051
    Package 00052569138113
    Package 10052569138110
    Package 00010939694447
    Package 10010939694444
    Package 00021292007386
    Package 10021292007383
    Package 00087701426179
    Package 10087701426176
    Package 00041260385124
    Package 10041260385121
    Package 00036800234499
    Package 10036800234496
    Package 00010939958754
    Package 10010939958751

    Customer Contacts

    Phone
    +1(800)803-6025
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K993017 000

    Device Sizes

    Type Value Unit Text
    Length 0.31 Inch
    Total Volume 1.0 Milliliter
    Needle Gauge 31 Gauge