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510(k) Data Aggregation

    K Number
    K983926
    Device Name
    MPS GRAVITY FLOW CONTROL SET
    Date Cleared
    1999-01-20

    (76 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs. The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.
    Device Description
    The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Gravity Flow Control Sets will be available in both primar I.V. sets and extension sets. It incorporates a standard bag spike, flexible drip chamber, PVC tubing, Clamp and ending with a standard male luer lock. Various flow rates are established by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet. Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Gravity Flow Control Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
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    K Number
    K964918
    Device Name
    NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
    Date Cleared
    1997-04-14

    (126 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use as a needleless alternative to IV set injection ports. The NIMATM adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. For use with standard luer taper connections. For single patient use.
    Device Description
    The NIMATM adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMATM adapter valve is opened by inserting a standard male luer taper, such as on an extension set, IV tubing or syringe to the female end of the NIMATM adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMATM adapter is packaged individually and as attached as part of extension sets
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    K Number
    K964989
    Device Name
    CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
    Date Cleared
    1997-04-02

    (110 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - For aspiration or iniection of medical from inverted multidose vials and bags - For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood bome pathogens such as HIV and HBV. - For use up to 24 hours, or in accordance with current guidelines of IV therapy. - For use with standard luer taper connections. - For singe patient use.
    Device Description
    The CDC Vial and Bag Access Pin are adapters which pierce a rubber stoppered drug vial and/or bag and allows access to the contents. The CDC Vial and Bag Access Pins will be available with and without a 2-way luer activated check valve or with an extension line. The luer activated check valve or extension line is used to prevent loss of medication during aspiration or injection from inverted vials or bags. The 0.45 micron air vent is used to eliminate air and particulates in the vial or bag contents during aspiration. The CDC Vial and Bag Access Pin are provided sterile and non-pyrogenic in sealed single unit pouches.
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    K Number
    K964812
    Device Name
    NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
    Date Cleared
    1997-02-10

    (73 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    a. For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection. b. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. C. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections. d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. e. For use with standard luer taper connections. f. For single patient use.
    Device Description
    The NIMA™ adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMA™ adapter valve is opened by inserting a standard male luer taper, such as on an extension set. IV tubing or syringe to the female end of the NIMA™ adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMA™ adapter is packaged individually and as attached as part of extension sets
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    K Number
    K952852
    Device Name
    NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
    Date Cleared
    1996-02-16

    (240 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955896
    Device Name
    MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
    Date Cleared
    1996-02-06

    (39 days)

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

    CRITICAL DEVICE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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