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510(k) Data Aggregation

    K Number
    K060109
    Device Name
    OMI RETRACTABLE SAFETY SYRINGE
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    2006-05-05

    (112 days)

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

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.
    Device Description
    The OMI Retractable Safety Syringe works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes. STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe. STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits. STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub. The syringe is EO sterilized, non-pyrogenic, and latex free.
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    K Number
    K050906
    Device Name
    VITALCARE I.V. ADMINISTRATION SET
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    2005-08-23

    (134 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.
    Device Description
    The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.
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    K Number
    K040916
    Device Name
    VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    2005-05-04

    (391 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between the patient and examiner.
    Device Description
    VitalCare Powder Free Synthetic Vinyl Examination Glove. A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment.
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    K Number
    K031748
    Device Name
    VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    2003-08-27

    (83 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.
    Device Description
    Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives. The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.
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    K Number
    K992289
    Device Name
    VINYL POWDERED EXAM GLOVE / CAT.# 15-020
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1999-08-04

    (28 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient Vinyl Exam Glove, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Vinyl, Patient Exam Gloves, Powdered
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    K Number
    K983016
    Device Name
    GAUZE, SPONGES, CAT # 11-003
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1999-02-12

    (168 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wound cover for patient care.
    Device Description
    Gauze, Sponges Various Sizes, Non-Sterile and Sterile
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    K Number
    K983716
    Device Name
    VITALCARE DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1998-12-23

    (63 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
    Device Description
    Disposable Nonmetal Vaginal Speculum
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    K Number
    K982901
    Device Name
    LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1998-12-21

    (126 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    VitalCare Exam Gloves (Latex), Paude
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