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510(k) Data Aggregation

    K Number
    K120118
    Device Name
    VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2012-05-24

    (128 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.
    Device Description
    Ventlab Pressure-Chek Disposable Column Manometer
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    K Number
    K102674
    Device Name
    CUFF SENTRY
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2011-07-22

    (309 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intracuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.
    Device Description
    Ventlab Cuff Sentry Cuff Inflation Device
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    K Number
    K093617
    Device Name
    VENTLAB 6000 SERIES HUMIDIFIER
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2011-01-27

    (430 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient. Its use is indicated whenever a physician or other healthcare provider prescribes humidification to patients receiving supplemental oxygen via oxygen tubing and nasal cannulae. This device is single patient use, non-sterile prescription device that is indicated in both hospital and homecare applications.
    Device Description
    The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient.
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    K Number
    K093525
    Device Name
    ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2009-12-10

    (24 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(51bs.).
    Device Description
    Not Found
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    K Number
    K090840
    Device Name
    VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2009-06-25

    (90 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K082204
    Device Name
    SERIES SY DISPOSABLE ELECTROSURGICAL PAD
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2008-08-13

    (8 days)

    Product Code
    ODR
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
    Device Description
    Not Found
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    K Number
    K063813
    Device Name
    VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2008-03-26

    (460 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab End-Tidal CO2 Nasal Cannula is an accessory to a carbon dioxide analyzer used when there is a need to measure the percentage of exhaled carbon dioxide of a nonintubated patient while administering oxygen during inhalation.
    Device Description
    Not Found
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    K Number
    K040726
    Device Name
    VENTLAB NASAL CPAP CANNULA
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2004-06-03

    (73 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy (i.e., CPAP, BiLevel).
    Device Description
    Ventlab Nasal CPAP Cannula
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    K Number
    K030271
    Device Name
    VENTLAB BACTERIAL FILTER, MODEL BF100
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2003-07-07

    (161 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.
    Device Description
    Ventlab Bacterial Filter BF100
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    K Number
    K020281
    Device Name
    MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2002-02-11

    (14 days)

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

    VENTLAB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.
    Device Description
    Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve
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