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510(k) Data Aggregation

    K Number
    K041038
    Device Name
    CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2004-12-21

    (243 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Churchill Medical Dual Chamber Empty Container is intended for indiodions For Society, and administration of total parenteral nutrition ( TPN ) solutions.
    Device Description
    The Churchill Medical Systems Dual Chamber Empty Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. This device is a sterile, single use disposable I.V. container that is horizontally divided into two chambers. The top chamber is intended for the storage of amino acid/ dextrose mixtures. The bottom chamber is intended to store lipid emulsions. Additive medication may be introduced into the bottom compartment by access through a non-latex injection port. The chambers are designed to be filled with TPN solution by a pharmacy operation. The filled container is intended to be stored with the divider/seal intact until the time of administration to the patient. At the time of patient use the divider/seal (Fig 1) is removed by peeling the external seal that separates the container top chamber from bottom chamber. The combined fluids are and then dispensed to the patient through a secondary set not included with this device. The container is made from extruded stock non-DEHP vinyl. Each chamber is provided with a Pharmacy filling port, filling port clamp, nonlatex injection site, and one patient delivery port located at the device bottom. All materials used and manufacturing processes are identical to the original All materials asou and and is a two-piece component that consists submission rod and a tightly fitting "U" shaped over piece. The of a contor synnditor and separated when the divider is placed over the exterior bag surface. The divider/seal does not contact any fluid or medication but, works to occlude the two chambers from one another by forming a compression seal when the bag is squeezed between.
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    K Number
    K021395
    Device Name
    MODIFICATION TO 30 EXTENSION SET
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-05-13

    (11 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids.
    Device Description
    Not Found
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    K Number
    K013949
    Device Name
    UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-03-27

    (117 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Churchill Medical Systems Vial Access Spike with Needleless Connector is used in I.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device climinates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.
    Device Description
    The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.
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    K Number
    K020544
    Device Name
    WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-03-12

    (25 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Churchill Medical Systems Wing Safe Huber Type Needle Sets intended use is for the delivery of medical fluids into implantable chemotherapy ports.
    Device Description
    Churchill Medical Systems Wing Safe Huber Needle Set
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    K Number
    K013950
    Device Name
    VENTED VIAL ACCESS DEVICE
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-01-10

    (41 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.
    Device Description
    The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.
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    K Number
    K012157
    Device Name
    CHURCHILL MEDICAL SYSTEMS STOPCOCK
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-09-11

    (62 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.
    Device Description
    The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion handle opens or closes each port.
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    K Number
    K011888
    Device Name
    PRESSURE ACTIVATED CHECK VALVE
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-09-10

    (84 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.
    Device Description
    The Churchill Medical Systems Pressure Activated Check Valve consists of acrylic-polycarbonate alloy valve body and a silicone valve with male and female luer lock connections. The device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents back flow.
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    K Number
    K011336
    Device Name
    PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-06-12

    (41 days)

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

    CHURCHILL MEDICAL SYSTEMS, INC.

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