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510(k) Data Aggregation

    K Number
    K213407
    Device Name
    UltiCare Disposable Pen Needles
    Date Cleared
    2021-12-16

    (58 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    UltiMed Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    The UltiCare™ Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The UltiCare™ Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare™ Disposable Pen Needles are non-toxic and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (5/32" to 1/2").
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    K Number
    K140949
    Device Name
    ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
    Date Cleared
    2015-02-09

    (301 days)

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

    ULTIMED INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UltiCare™ Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries.
    Device Description
    The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is a standard piston type syringe with a removable needle and protective shield. This sterile, single-use, disposable 3 ml piston syringes consist of a syringe barrel, plunger rod with gasket, removable single lumen needle, needle cap, and protective shield. The UltiCare Safety Syringes are non-toxic and non-pyrogenic, and will be available in a range of needle gauges and lengths between the smallest (27G x 5/16") and the largest (21G x 1 1/2").
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