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510(k) Data Aggregation

    K Number
    K142096
    Device Name
    T-PIECE RESUSCITATOR
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2014-10-17

    (77 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).
    Device Description
    The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb). It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure. The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.
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    K Number
    K093913
    Device Name
    MERCURY MEDICAL T-PIECE RESUSCITATOR
    Manufacturer
    MERCURY MEDICAL, INC.
    Date Cleared
    2010-04-06

    (105 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCURY MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo-Tee™ T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb).
    Device Description
    The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants < 10 kg (22 lb). It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure. The Mercury Medical T-Piece Resuscitator (Neo-Tee™) can be connected to the patient via a face mask or endotracheal tube.
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    K Number
    K090710
    Device Name
    MERCURY CPAP
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2009-08-20

    (155 days)

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

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
    Device Description
    The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.
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    K Number
    K081266
    Device Name
    MERCURY MEDICAL PEEP VALVE
    Manufacturer
    MERCURY ENTERPRIZES DBA MERCURY MEDICAL
    Date Cleared
    2009-03-05

    (304 days)

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

    MERCURY ENTERPRIZES DBA MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.
    Device Description
    Not Found
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    K Number
    K083056
    Device Name
    NEO-STAT CO2 <KG
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2009-02-23

    (132 days)

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

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.
    Device Description
    Mercury Medical, Inc. Neo-StatCO2 <Kg is a colorimetric breath indicator for visualization of exhaled CO2. It is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. Color change is rapid and the detector has the ability to show color changes with 1 ml tidal volume and up to a respiratory rate of 100 breaths per minute. The detector may be used during patient transport or in locations when intubations are performed. While the indicator functions at relative humidity (RH) of up to 100%, it is not recommended for use below 10% RH. It may be used for up to 24 hours.
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    K Number
    K032593
    Device Name
    MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2004-02-03

    (165 days)

    Product Code
    BXR
    Regulation Number
    868.1780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.
    Device Description
    The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.
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    K Number
    K031814
    Device Name
    STATCO2METER, MODEL 10-55372
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2003-08-14

    (63 days)

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

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
    Device Description
    The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. The detector may be used during patient transport or in locations where intubations are performed.
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    K Number
    K031411
    Device Name
    MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2003-07-30

    (86 days)

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

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical Mini StatCO2™ End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
    Device Description
    The Mercury Medical Mini StatCO2™ uses the same technology as the Nellcor Pedi-CAP™ (K944400). The Mini StatCQ2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.
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    K Number
    K021576
    Device Name
    MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2002-11-04

    (174 days)

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

    MERCURY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical STATCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
    Device Description
    The Mercury Medical STATCO2™ uses the same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter). The STATCO2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.
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    K Number
    K001714
    Device Name
    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2000-11-03

    (151 days)

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

    MERCURY MEDICAL

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