| Primary Device ID | 20637320035005 |
| NIH Device Record Key | c3210684-b3a7-4850-9814-090cce7d6a46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VAR-Monitor |
| Version Model Number | VM-3500 |
| Catalog Number | VM-3500 |
| Company DUNS | 090508636 |
| Company Name | VORTRAN MEDICAL TECHNOLOGY 1, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 20637320062001 - VORTRAN GO2VENT with PEEP Valve | 2021-05-12 The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, |
| 10637320039600 - VORTRAN® APM-Plus | 2020-02-07 The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for m |
| 20637320060014 - VORTRAN GO2VENT | 2019-05-13 The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure control or pressure support mo |
| 10637320000112 - VORTRAN GO2VENT | 2019-04-29 The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressure control
or pressure support modes on |
| 20637320035005 - VAR-Monitor | 2018-07-06The 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 |
| 20637320035005 - VAR-Monitor | 2018-07-06 The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the V |
| 20637320039003 - VORTRAN Airway Pressure Monitor | 2018-07-06 The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via th |
| 20637320040702 - E-Surge Kit | 2018-06-12 Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20 |
| 20637320050503 - VAR Surgical Center Kit | 2018-06-12 Kit Contains: 3 each VAR Model PCM-5011; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung |