VORTRAN MEDICAL TECHNOLOGY 1, INC

Address:21 Goldenland Court,SACRAMENTO,CA,95834,US

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Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class :

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VAR® device is a unique single-patient-use, disposable resuscitator. It prov 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6001

Device Description : The GO2VENT provides constant fl ow, pressure cycled ventilatory support in eith 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).

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN Pressure Manometer provides pressure readings from a breathing circu The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN Pressure Manometer provides pressure readings from a breathing circu The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel 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.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1