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510(k) Data Aggregation

    K Number
    K172804
    Device Name
    Besmed Peak Flow Meter
    Manufacturer
    Besmed Health Business Corp.
    Date Cleared
    2018-01-11

    (115 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Besmed Health Business Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended device measures a patient's peak expiratory flow rate liters/minute.
    Device Description
    The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.
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    K Number
    K160112
    Device Name
    Besmed PEEP Valve
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2016-04-29

    (101 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.
    Device Description
    Not Found
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    K Number
    K150591
    Device Name
    Besmed Reusable Jet Nebulizer
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2015-06-30

    (113 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.
    Device Description
    The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient.
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    K Number
    K143150
    Device Name
    CO2 monitoring line with and without in-line filter
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2015-02-05

    (94 days)

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

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CO2 Monitoring Lines are intended to connect from a CO2 sampling port to the expired gas monitor.
    Device Description
    The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas sampling equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.
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    K Number
    K140370
    Device Name
    DISPOSABLE PRESSURE MANOMETER
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2014-06-19

    (125 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits, For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home. Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
    Device Description
    The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: 1. A flexible nipple for attachment to a sampling / pressure port. 2. Clear housing with a printed pressure scale 3. A float with indicator 4. Spring. When positive pressure is present in the ventilation device, the manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range - 0-60 cm H2O. Besmed intends offer three (3) models / styles of their disposable pressure manometer. They are identical in design, function and materials. The differences are: Pressure range. 0 0 60 cm H2O 0 40 cm H2O · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design Note the accuracy and performances are identical . Indicator strip . O All models have the pressure range embossed on the housing o A color strip / indicator may also be included to indicate the pressure. It is a single patient, disposable, packaged non-sterile device.
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    K Number
    K133873
    Device Name
    TRIBALL INCENTIVE SPIROMETER
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2014-04-04

    (105 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.
    Device Description
    The Besmed TriBall Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200). It is a single patient, multi-use, disposable, non-sterile device. As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers". The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.
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    K Number
    K091272
    Device Name
    BESMED JET NEBULIZER BOTTLE SET
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2009-11-10

    (194 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
    Device Description
    The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.
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    K Number
    K031374
    Device Name
    BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2003-11-28

    (212 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. - Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
    Device Description
    Besmed various models of TENS, BE-550 / BE-660
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    K Number
    K031375
    Device Name
    BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2003-11-20

    (204 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BESMED HEALTH BUSINESS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion. Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
    Device Description
    Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580
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