VORTRAN MEDICAL TECHNOLOGY 1, INC

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Positive Pressure Breathing, Intermittent (NHJ) (2) Compressor, Air, Portable (BTI) (1) Ventilator, Emergency, Powered (Resuscitator) (BTL) (1)

Premarket Exempt

No Yes

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VORTRAN PercussiveNEB 2.0 - 10637320080305 Catalog Number : 8030

Device Description : The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that inco The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that incorporates a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1

VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port - 10637320080404 Catalog Number : 8040

Device Description : The PercussiveNEB 2.0 with Top Nebulizer Port is an intrapulmonary percussive tr The PercussiveNEB 2.0 with Top Nebulizer Port is an intrapulmonary percussive treatment device that can incorporate a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : NHJ

Prescription Use : Yes

Device Count : 1

VORTRAN Medical Air Compressor - 10637320081005 Catalog Number : 8100

Device Description : The VORTRAN Medical Air Compressor is a compressor designed for continuous, high The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

VAR-Monitor - 20637320035005 Catalog Number : VM-3500

Device Description : The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the VAR stops cycling, the VAR-Monitor™ detects the non-cycling condition and generates both an audible sound and a visible blinking (red color LED) light alerting the clinician who is attending the patient.

Device Class : 2

Duns Number: 090508636

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

E-Surge Kit - 20637320040702 Catalog Number : ES-4070

Device Description : Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flo Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20' Heavy Duty Oxygen Hose; 1 each Watertight Carrying Case; 10 each HME Filters

Device Class :

Duns Number: 090508636

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

VAR Surgical Center Kit - 20637320050503 Catalog Number : PCK-5050

Device Description : Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Traini Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung

Device Class :

Duns Number: 090508636

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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