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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans.
VORTRAN MEDICAL TECHNOLOGY 1, INC
PT-5000
In Commercial Distribution

  • 10637320050001 ()
  • 20637320050008 ()
PT-5000

  • Pulmonary resuscitator, pneumatic, single-use
The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for safety. The working mechanism of the GO2VENT consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).
VORTRAN MEDICAL TECHNOLOGY 1, INC
6123-16
In Commercial Distribution

  • 20637320000164 ()
  • 10637320000167 ()
6123-16

  • Pulmonary resuscitator, pneumatic, single-use
The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
VORTRAN MEDICAL TECHNOLOGY 1, INC
6200
In Commercial Distribution

  • 20637320062001 ()
  • 10637320062004 ()
6200

  • Pulmonary resuscitator, pneumatic, single-use
The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas fl ow, entrain additional air, and provides a redundant pop-off valve for safety. The working mechanism of the GO2VENT consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will aff ect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the fi nal adjustments are made in a secured position (strapped or taped to the patient).
VORTRAN MEDICAL TECHNOLOGY 1, INC
6600
In Commercial Distribution

  • 10637320000112 ()
  • 20637320000119 ()
6600

  • Pulmonary resuscitator, pneumatic, single-use
The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for safety. The working mechanism of the GO2VENT consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).
VORTRAN MEDICAL TECHNOLOGY 1, INC
6123
In Commercial Distribution

  • 20637320000102 ()
  • 10637320000105 ()
6123

  • Pulmonary resuscitator, pneumatic, single-use
CAREvent ALS+ CPAP is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ CPAP also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. In addition, CAREvent ALS+ CPAP has an adjustable CPAP/PEEP mode, eliminating the need for an external PEEP valve or CPAP device.
O-Two Medical Technologies Inc
01CV4000-CPAP
In Commercial Distribution

  • 07540195025325 ()
  • 07540195025318 ()

  • Weight: 1.5 Kilogram
  • Height: 2.95 Inch
  • Width: 5.5 Inch
  • Length: 8.1 Inch
01CV4000-CPAP

  • Pulmonary resuscitator, pneumatic, reusable
CAREvent ALS+ is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
O-Two Medical Technologies Inc
01CV4000
In Commercial Distribution

  • 07540195025295 ()
  • 07540195025301 ()

  • Weight: 1.5 Kilogram
  • Height: 2.95 Inch
  • Width: 5.5 Inch
  • Length: 8.1 Inch
01CV4000

  • Pulmonary resuscitator, pneumatic, reusable
CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent DRA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent DRA allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
O-Two Medical Technologies Inc
01CV3000-DRA
In Commercial Distribution

  • 07540195025233 ()
  • 07540195025240 ()

  • Weight: 0.45 Kilogram
  • Height: 2.9 Inch
  • Width: 2.5 Inch
  • Length: 5.5 Inch
01CV3000-DRA

  • Pulmonary resuscitator, pneumatic, reusable
CAREvent CA hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent CA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS, CA, DRA and Genesis II allow the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The CAREvent CA is designed for resuscitation in toxic environments. A constant bleed flow reduces the risk of a patient drawing toxic air into the mask should a leak occur.
O-Two Medical Technologies Inc
01CV3000-CA
In Commercial Distribution

  • 07540195025202 ()
  • 07540195025196 ()

  • Weight: 0.45 Kilogram
  • Height: 2.9 Inch
  • Width: 2.5 Inch
  • Length: 5.5 Inch
01CV3000-CA

  • Pulmonary resuscitator, pneumatic, reusable
CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent ALS delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
O-Two Medical Technologies Inc
01CV3000
In Commercial Distribution

  • 07540195025165 ()
  • 07540195025158 ()

  • Weight: 0.45 Kilogram
  • Height: 2.9 Inch
  • Width: 2.5 Inch
  • Length: 5.5 Inch
01CV3000

  • Pulmonary resuscitator, pneumatic, reusable
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