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510(k) Data Aggregation

    K Number
    K063650
    Device Name
    VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2007-02-15

    (69 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 840 Ventilator with Respiratory Mechanics Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (Vr 5-2500 mL with NeoMode) or from infant to adult (VJ-25-2500 mL). The 840 Ventilator with Respiratory Mechanics is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
    Device Description
    The Respiratory Mechanics Option enables the 840 Ventilator System to implement three new respiratory maneuvers, and permits the device to calculate and display ten additional measurements for use in the assessment of mechanical pulmonary functions of the patient's airways. The Respiratory Mechanics feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).
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    K Number
    K053388
    Device Name
    MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2006-04-04

    (120 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive. PAV+ is intended for use in hospitals and hospital-type facilities.
    Device Description
    Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator that includes a spontaneous breath type called, Proportional Assist. PAV+ is designed to assist the spontaneous breathing patient with an active neural drive. Proportional Assist amplifies the patient's inspiratory effort. A control function allows the clinician to specify an amplification setting.
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    K Number
    K023225
    Device Name
    PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2002-12-18

    (82 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Puritan Bennett DataFlow™ Data Management Software is intended to augment the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System's data management capability.
    Device Description
    Puritan Bennett DataFlow™ Data Management Software is a software program used in conjunction with the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System to transfer patient test data from the spirometer to an IBM compatible Personal Computer. Once transferred, the DataFlow software allows the operator to perform any or all of the following: edit or add patient demographic information, archive the test, search for and retrieve archived test(s), print test reports, compare archived tests, and export test data for use by other application software.
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    K Number
    K022103
    Device Name
    PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2002-09-27

    (91 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PB700 Renaissance II Spirometry System is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health testing environments.
    Device Description
    The PB700 Spirometry System consists of the Renaissance II Spirometer, the PB710 Base Station, AC Adapter, the disposable FSII Flow Sensor, a syringe adapter (for calibration), and nose clips. Optional accessories include calibration syringe, printer and serial communications cables, and a compatible printer. The Renaissance II Spirometry System is designed for use in the diagnosis, assessment, and monitoring of certain lung diseases.
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    K Number
    K001646
    Device Name
    PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2000-10-20

    (143 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002001
    Device Name
    BREEZE SLEEPGEAR WITH DREAMSEAL
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    2000-09-06

    (68 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993071
    Device Name
    PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    1999-11-24

    (71 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
    Device Description
    The 840 Ventilator System is a "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as Class I, Type B equipment, per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves, PSOLs and an active expiratory valve. Previously cleared modes of ventilation include Assist Control, AC, Synchronized Intermittent Mandatory Ventilation, SIMV and Spontaneous, SPONT. The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure, PEEP, trigger sensitivity and oxygen concentration. A mandatory breath can be either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support. This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.
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    K Number
    K993220
    Device Name
    PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    1999-10-22

    (25 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications.
    Device Description
    The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The vacuum insulated container allows oxygen to be stored in its liquid state under pressure where the system pressure is controlled by the relief valve. When the patient opens the flow control valve, the liquid oxygen is withdrawn from the container into a vaporizing coil. Once in the vaporizing coil, ambient heat is absorbed by the liquid oxygen, converting it into a gas and warming it to near room temperature. The gas finally passes through the flow control valve and on to the patient at the prescribed metered rate. The device is intended to be used in conjunction with a larger liquid oxygen reservoir where it is filled by mating it to the fill connection on the top of the larger system. The Helios device is a purely mechanical device and contains no electrical or electronic components.
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    K Number
    K993088
    Device Name
    PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    1999-10-08

    (22 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Puritan-Bennett Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used with both pediatric and adult patients. It is not intended as life sustaining or life supporting device. The device has no contraindications.
    Device Description
    An oxygen concentrator takes in room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient while exhausting a nitrogen-rich air mixture back into the room. The principle components of the Aeris 590 oxygen concentrator include a compressor, two molecular sieve containers, a valve system and a printed circuit board. The compressor draws in room air, pressurizes it and forces it through the pneumatic circuit of the device. As the air passes through one sieve container, the nitrogen bonds with the molecular sieve material within the pressurized container and allows only the oxygen and trace gases to flow out of the container. This oxygen rich mixture (+90% oxygen) is then delivered to the patient at a regulated pressure and flowrate. The valve system regulates the airflow through the sieve containers alternately. While one is pressurized and producing oxygen, the other is being depressurized and exhausting the nitrogen in preparation for the next cycle. A programmable logic device on the printed circuit board controls the timing of this cycling process. The OCI (Oxygen Concentration Indicator) provides an indication of the oxygen concentration of the output gas and includes alarm features.
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    K Number
    K984535
    Device Name
    PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
    Manufacturer
    PURITAN BENNETT CORP.
    Date Cleared
    1998-12-28

    (7 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN BENNETT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 840 Ventilator System with BiLevel Option is used to provide continuous ventilation to patient's requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
    Device Description
    The 840 Ventilator System is a Class II device, "Continuous Ventilator", per 21 CFR Part 868.5895. This device is designated a Class I Type B equipment per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves (PSOLs) and an active expiratory valve. Previosly cleared modes of ventilation include Assist Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV), and Spontaneous (SPONT). The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure (PEEP), trigger sensitivity, and oxygen concentration. A mandatory breath can be pressure- or volume-controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath mode allows the patient inspiratory flows of up to 200 L/min, with or without pressure support. The 840 Ventilator modification is the addition of two new features for this device, the BiLevel Option and Inspiratory Pause. The BiLevel mode and Inspiratory Pause features are implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "BiLevel" has been added as a mode choice in the touch screen MODE menu. The INSP PAUSE key on the user interface, is activated to perform the inspiratory pause function. The pneumatic design and the electrical circuitry (apart from the User Interface printed circuit board) has remained unchanged functionally.
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