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510(k) Data Aggregation

    K Number
    K180510
    Device Name
    NS 120P-TRS Airway Pressure Gauge
    Manufacturer
    Instrumentation Industries, Inc.
    Date Cleared
    2019-05-01

    (428 days)

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

    Instrumentation Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.
    Device Description
    The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.
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    K Number
    K162753
    Device Name
    RTC 26-C Inline Aerosol Adapter
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2017-02-28

    (151 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
    Device Description
    The Instrumentation Industries, Inc. RTC 26-C Inline Aerosol Adapter is a single-patient reuse device intended to provide an access port in a ventilator circuit to facilitate the administration of Combivent® (ipratropium bromide and albuterol) Respimat® medication to mechanically ventilated patients.
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    K Number
    K113644
    Device Name
    PILOT TUBE REPAIR KIT
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2012-01-26

    (45 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube. This device is intended for sale by or on the order of a physician. The BE 409 Pilot Tube Repair Kit is intended for single patient use.
    Device Description
    The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter. The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package.
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    K Number
    K102127
    Device Name
    ENDOTRACHEAL TUBE CHANGERS
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2010-08-27

    (29 days)

    Product Code
    LNZ
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.
    Device Description
    The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.
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    K Number
    K101857
    Device Name
    RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2010-07-22

    (20 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
    Device Description
    The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers.
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    K Number
    K091111
    Device Name
    RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2009-12-02

    (229 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-V MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician. The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
    Device Description
    The Instrumentation Industries, Inc. RTC 24-V metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 24-V metered dose inhaler adapter kit is comprised of the Instrumentation Industries, Inc. components normally used by respiratory therapists to integrate our existing actuators into a ventilator circuit. The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm ID tubing and one 15mm ID/22mm OD adapter.
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    K Number
    K081778
    Device Name
    NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2008-09-12

    (81 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. These devices are intended to be used by or on the order of a physician. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician.
    Device Description
    The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm. H20, dependent upon the specific model used.
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    K Number
    K081693
    Device Name
    NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2008-09-11

    (86 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.
    Device Description
    The NS Series NIF Meters are intended to measure inspiratory airway pressures of up to 30, 60 or 120 cm H2O , dependent upon the specific model used.
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    K Number
    K991355
    Device Name
    METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2000-01-27

    (283 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use. The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
    Device Description
    Not Found
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    K Number
    K992670
    Device Name
    OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    1999-09-17

    (88 days)

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

    INSTRUMENTATION INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
    Device Description
    Oxygen Enrichment Kit
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