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510(k) Data Aggregation

    K Number
    K103011
    Device Name
    ULTICARE SAFETY INSULIN SYRINGE
    Manufacturer
    ULTI-MED INTL., INC.
    Date Cleared
    2011-02-02

    (113 days)

    Product Code
    MEG, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTI-MED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.
    Device Description
    The UltiCare Safety Insulin Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. These syringes are sterile, single-use, disposable piston syringes consisting of a syringe barrel calibrated in units of insulin (U-100), plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield. The UltiCare Safety Insulin Syringes are non-toxic and non-pyrogenic, and will be available in numerous sizes and combinations between the smallest (0.3 ml x 31G x 5/16 ") and the largest (1 ml x 29G x 1/2 ").
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