VORTRAN MEDICAL TECHNOLOGY 1, INC

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

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- Catalog Number : 6123

Device Description : The GO2VENT provides constant flow, pressure cycled ventilatory support in eithe 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).

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6600

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 controlor pressure support modes on patients weighing 10kg and above. The device includes the pulmonarymodulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector teeto supply gas fl ow, entrain additional air, and provides a redundant pop-off valve for safety. Theworking mechanism of the GO2VENT consists of a moving diaphragm which adds or subtractsspring force when it is moved from a horizontal to a vertical position, the addition or subtraction ofspring force will aff ect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position aslong as the fi nal adjustments are made in a secured position (strapped or taped to the patient).

Device Class :

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6123-16

Device Description : The GO2VENT provides constant flow, pressure cycled ventilatory support in either 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).

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to mea The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BSK

Prescription Use : Yes

Device Count : 1

Device Description : The APM (Airway Pressure Monitor) is a battery operated, portable, self-containe The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via the connection kit to monitor the cycling conditions of resuscitators. It give clinicians patient ventilation parameters (PIP, PEEP, Respiration Rate, I:E ratio) and provides visual alarm display with flashing LED and loud audible alarm. It allows clinicians to have a true value of patient status during ventilation similar to a full-featured ventilator. It is easy to set up and use. Offers different connection kit options.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or bubble CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure and includes a number of associated accessories. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

- Catalog Number : IP-4020

Device Description : The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. I The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1

Device Description : The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. I The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : PNB-4030

Device Description : The PercussiveNEB® device is a single-patient use percussor, which makes it poss The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1