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510(k) Data Aggregation

    K Number
    K100812
    Device Name
    ULTICARE DISPOSABLE PEN NEEDLES
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2010-06-03

    (72 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltiCare Disposable Pen Needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    The UltiCare Disposable Pen Needles are sterile, single-use, Type A, hypodermic single lumen needles designed for use with insulin pen injector devices. 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 non-pyrogenic, and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (3/16" to 1/2").
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    K Number
    K080600
    Device Name
    ULTIMED ULTICARE SAFETY SYRINGE
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2008-06-25

    (114 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltiMed UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety shield aids in the prevention of needle stick injuries.
    Device Description
    The UltiMed UltiCare Safety Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, plunger rod with gasket, permanently attached hypodermic single lumen needle, needle cap, and protective shield. The UltiMed UltiCare Safety Syringes are non-toxic and nonpyrogenic, and will be available in a variety of combinations of syringe sizes (0.5 to 3.0 ml (cc)), needle sizes (27 to 21 gauge), and needle lengths (5/16" to 1½''). The protective shield is made of clear plastic and is furnished in a retracted position with the needle cap over the needle. When the needle cap is removed, medication can be drawn and injected in the conventional manner. After the injection, the protective shield is engaged by sliding it away from the finger grip to an extended position over the needle and then applying a turning or rotating motion to lock the shield in place.
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    K Number
    K081449
    Device Name
    ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2008-06-03

    (11 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
    Device Description
    The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen needles can be removed from the dispenser as needed, and used pen needles can be removed and deposited back into the top of the container for safe storage. When all 100 pen needles have been used and discarded into the container, the container is disposed according to local regulations. The disposable pen needles and UltiGuard container are intended for single use only.
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    K Number
    K062702
    Device Name
    ULTICARE DISPOSABLE SYRINGES AND NEEDLES
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2006-11-29

    (79 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin. The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.
    Device Description
    The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").
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    K Number
    K033794
    Device Name
    ULTICARE DISPOSABLE SYRINGE 3 ML/CC
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2003-12-30

    (25 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltiCare Disposable Syringe is used to draw a quantity of pharmaccutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
    Device Description
    The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored protective needle cap. This device is a sterile, single-use, disposable piston svringe with permanently affixed hypodermic single lumen needle. This device is a sterile, single use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The UltiCare 3 ml Disposable Syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The UltiCare 3 ml Disposable Syringe is available in a 3.0 cc syringe capacity with a 22 GAUGE x 1½" hypodermic single lumen needle.
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    K Number
    K994230
    Device Name
    ULTICARE DISPOSABLE SYRINGE
    Manufacturer
    ULTIMED, INC.
    Date Cleared
    2000-03-24

    (99 days)

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

    ULTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
    Device Description
    The Ulti Care Low Dead Space syringe is substantially equivalent to the Becton Dicksnson MedSaver The syringe. The device is intended to minimize the consumption of expensive pharmacenticals by reducing the distance between the calibrated barrel of the syringe and the needle. The devise has a permanently attached needle that eliminates the tip and hub-of a normal needle/syringe combination. This results in less waste of pharmaceutical and greater efficiency. The intended device has the same technological characteristics as the presently marketed Becton Dickinson MedSaver using a manually operated piston type hypodemic syringe, injected molded plastic parts, a synthetic latex gasket and permanently attached stainless steel needle.
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