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510(k) Data Aggregation
K Number
K133196Device Name
IMPACT MODEL 323 ASPIRATOR
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2014-03-10
(144 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for use in removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials from wounds, either during surgery or at the patient's bedside. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments. The Model 323 is only for use by or on the order of a physician.
Device Description
The IMPACT® Model 323 Aspirator is a completely self-contained suction source. It is lightweight, compact, easy to use and is easy to clean. It features a vacuum gauge, integral mounting hardware, power switch, rechargeable batteries, adjustable vacuum regulator, 800 cc collection container, integral carry handle, and convenient stowage of the container holders. The device is housed within an injection molded plastic case.
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K Number
K111473Device Name
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2012-02-16
(265 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an "MRI conditional" label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+® and Eagle II'" (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV® (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).
Device Description
The Model 731 Ventilators are a small, extremely durable, full-featured portable mechanical ventilators designed to operate in hospitals or austere and under-resourced environments. The unit is a volume and pressure targeted, time or flow cycled ventilator designed to use either oxygen (O2) from a 55 psig source or fresh air using its internal compressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intended for continuous noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2 sensor). The unit contains various controls and indicators that are placed to facilitate ease of use and visibility in all operating environments. A liquid crystal display (LCD) provides continuous display of control settings, operating conditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alert the operator and guide their actions to resolve the alarm condition and assure patient safety. At the onset of an alarm, the screen displays the alarm name and then a series of context-sensitive help messages. These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When multiple alarms occur they are prioritized and displayed based on the risk to the patient. The unit offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient. Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target. Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported demand flow or supported using Pressure Support. (This mode is not available in the AEV® unit.) Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support. The unit contains a built-in back up ventilator mode that is designed to provide a limited degree of operation should certain types of failures occur to the primary operating system. The unit can be used in environments where chemical and/or biological toxins are present. To do this safely, all gas delivered to the patient comes from either a pressurized medical-grade O₂ source and/or filtered ambient air entrained through the FRESH GAS/EMERGENCY AIR INTAKE. Operators can chose between a bacterial/viral filter and a chemical/biological filter based on the direction of the Medical Control Officer. To prevent the patient from breathing contaminated ambient air in the event of a ventilator failure, the unit contains an internal anti-asphyxia valve that allows the patient to inspire gas through the external filter. The unit continuously monitors environmental conditions (temperature and ambient pressure) and when extreme environments are detected the operator is alerted by a low priority alarm which defines the operating condition and prompts the actions of the operator. The unit uses a rechargeable lithium-ion battery which offers a wide temperature operating range, does not exhibit "memory" characteristics (reduced capacity) or vent hydrogen gas. The unit can use O₂ from low flow sources, O₂ flow meters and O₂ concentrators, to provide supplemental O₂ to patients. To do this, O₂ is entrained through the Fresh Gas/Emergency Air Intake when the unit's internal compressor cycles to deliver a breath. The testing in MRI environment was done with a 3.0 T Siemens Trio scanner, which has a magnetic field of 0.2 T (500 gauss) at a distance of slightly more than 1 meter (~3.3 feet) from the bore entrance. There was no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters.
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K Number
K103318Device Name
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2011-04-07
(146 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Device Description
MODES OF OPERATION
The EMV+ offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient.
Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target.
Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)
Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support.
ADDITIONAL ADJUNCTS OF OPERATION
In addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits.
Mode Breath Target Pressure Support (PS) Noninvasive Positive Pressure Ventilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes
Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.
Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target.
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K Number
K091238Device Name
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2009-08-13
(108 days)
Product Code
CBK, DOA, DQA
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Device Description
The Uni-Vent ® Model 731EMV+ is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an externating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.
The Uni-Vent ® Model 731EMV+ internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.
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K Number
K071526Device Name
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2008-12-10
(555 days)
Product Code
CBK, DQA
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 731EMV (EMV) is indicated for use in the management of adolescent and adult patients weighing ≥30 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport, and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
Device Description
The Uni-Vent @ Model 731EMV is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an external alternating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.
The Uni-Vent @ Model 731EMV internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.
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K Number
K051476Device Name
UNI-VENT MODEL 73X
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2005-10-28
(147 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K032386Device Name
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2004-03-26
(235 days)
Product Code
BTL, PRE
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 730 AEV ™ is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, fransport, aeromedical and pre-hospital (BLS through ATLS) environments.
Device Description
Model 730 AEVTM is a portable, electronically controlled ventilator. It is controlled by an internal microprocessor (CPU), which continuously monitors and displays airway pressure, control settings, high-pressure alarm setpoint, gas volumes, and power signals. Two CPR and two Quick-Start Modes are available- one each is for use with unintubated patients (Mask) and one each is for use with intubated patients (Tube). This product operates from internal rechargeable batteries, external AC and 11-15 volts DC.
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K Number
K022062Device Name
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
Manufacturer
IMPACT INSTRUMENTATION, INC.
Date Cleared
2003-05-06
(315 days)
Product Code
MOD, CLA
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
IMPACT INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.
Device Description
The Impact, Universal Single-Limb, Portable Ventilator Circuit is comprised of disposable connectors, tubing and exhalation valve.
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