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510(k) Data Aggregation

    K Number
    K981114
    Device Name
    MICROCAP
    Manufacturer
    ORIDION MEDICAL LTD.
    Date Cleared
    1998-06-25

    (90 days)

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

    ORIDION MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of the Microcap capnograph monitor is indicated whenever a professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
    Device Description
    Not Found
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    K Number
    K980324
    Device Name
    MICROSTREAM FILLERLINE OR/EMS
    Manufacturer
    ORIDION MEDICAL LTD.
    Date Cleared
    1998-04-16

    (78 days)

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

    ORIDION MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO2 IN AN INTUBATED PATIENT'S BREATHING.
    Device Description
    The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a male Luer lock at one end of the device for connecting to the airway adapter in the ventilator or anesthesia machine airway and a female Luer lock on the other end for connecting to the capnograph. The two connectors are joined by a plastic tube and an in line hydrophobic filter. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation. The most common way (for intubated patients) to connect the sampling tube to a point where it can get a sample of the patients breathing is to connect one end of the sample tube to a point on the ventilator or anesthesia machine airway circuit. The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The Microstream Filterline OR/EM has integrated an in line hydrophobic filter between the patient and the Capnograph to reduce the amount of patient generated moisture that can enter the capnograph.
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    K Number
    K980325
    Device Name
    MICROSTREAM NASAL CANNULA FILTERLINE
    Manufacturer
    ORIDION MEDICAL LTD.
    Date Cleared
    1998-04-16

    (78 days)

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

    ORIDION MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE MICROSTREAM FILTERLINE NC DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO₂ IN A PATIENT'S BREATHING IN A NON INTUBATED PATIENT.
    Device Description
    The common product name for this device is a gas sampling nasal cannula . The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose and a female Luer lock on the Other end for connecting to the capnograph. The design and construction of the nasal cannula is almost identical to the nasal oxygen cannula 21 CFR 868.5340. The main difference is that instead of flowing oxygen through the cannula to the patient we use a vacuum to draw a sample of the breathing from the patient. The two connectors are joined by a plastic tube and an in line hydrophobic filter. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's Breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation. The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The microstream nasal cannula filterline has integrated an in line hydrophobic filter between the patient and the capnograph to reduce the amount of patient generated moisture that can enter the capnograph.
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    K Number
    K980327
    Device Name
    MICROSTREAM FILTERLINE ICU
    Manufacturer
    ORIDION MEDICAL LTD.
    Date Cleared
    1998-04-16

    (78 days)

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

    ORIDION MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microstream Filterline ICU device is used whenever the physician needs to measure the CO2 in an intubated patient's breathing.
    Device Description
    The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Male Luer Lock at one end of the device for connecting to the Airway Adapter in the ventilator or Anesthesia Machine Airway and a Female Luer Lock on the other end for connecting to the Capnograph. The two connectors are joined by a plastic tube an in line hydrophobic filter and an in line Nafion (K881264A) moisture membrane tube. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.
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