Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K050066
    Device Name
    C-CO2 COLORIMETRIC CO2 INDICATOR
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    2005-03-01

    (48 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.
    Device Description
    A non-sterile, single use, colorimetric carbon dioxide indicator with integral luer-lock connector, for placement in a gas sampling ported component, located between a tracheal tube and the breathing circuit, to detect exhaled CO2. Pressure in the breathing circuit causes a low flow of breathing gas to pass into and through the indicator and vent to the atmosphere. The colorimetric media in the center window of the device indicates the presence of carbon dioxide in exhaled breath on a breath-by-breath basis. The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present. A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color. The indicator has a color scale against which the actual color may be compared to provide an approximate carbon dioxide concentration. Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator.
    Ask a Question
    K Number
    K970478
    Device Name
    SCT 3000 HEATED HUMIDIFIER
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-16

    (159 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.
    Device Description
    Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.
    Ask a Question
    K Number
    K962220
    Device Name
    HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-01-14

    (218 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.
    Device Description
    Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.
    Ask a Question
    K Number
    K962223
    Device Name
    WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-01-14

    (218 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.
    Device Description
    The humidifier chambers offered for use with the SCT 3000. - * Adult low flow humidifier chamber - * Adult extended run humidifier chamber - * Pediatric low compressible volume humidifier chamber - * Adult hi flow humidifier chamber
    Ask a Question
    K Number
    K960972
    Device Name
    DISPOSABLE GAS SAMPLING INTERFACE KITS
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-10-18

    (221 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When a sample of a patient's expired gas is to be analyzed.
    Device Description
    The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter
    Ask a Question
    K Number
    K961838
    Device Name
    RESPIRGARD II, SPIROGARD
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-10-18

    (158 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARQUEST MEDICAL PRODUCTS, INC.

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

    Page 1 of 1