Vortran GO2VENT With Peep Valve
The VORTRAN GO2VENT with PEEP Valve provides emergency breathing support for patients weighing at least 10 kilograms. It uses a constant gas flow and pressure controlled cycling for short…
The VORTRAN GO2VENT with PEEP Valve provides emergency breathing support for patients weighing at least 10 kilograms. It uses a constant gas flow and pressure controlled cycling for short term ventilation. Properly trained personnel connect it to a face mask or airway tube through its patient connector.
A moving diaphragm opens the exhalation path at peak inspiratory pressure and closes it at the positive pressure maintained after exhalation. The added PEEP valve raises that closing pressure. The device can cycle automatically in pressure control mode or allow the patient to initiate inhalation in pressure support mode.
Listed Item
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.
Pressure Controls
Manual knobs adjust the spring force and exhalation flow resistance. A mechanical manometer displays inspiratory and end expiratory pressures so the operator can monitor the pressure cycle.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Vortran Medical Technology 1, Inc., United States |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K202219 |
| Record published | 2021-05-04 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6200 | In distribution | |
| 6123 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Support Products | Allied Medical LLC | 50 |
| Neo-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 45 |
| Pneupac | ICU Medical, Inc | 38 |
| Allied Medical LLC | Allied Medical LLC | 19 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 18 |
| AincA | Anesthesia Associates, Inc. | 17 |
| Neo-Tee T-Piece Resuscitator Circuit | Mercury Medical Enterprises, LLC | 12 |
| Life Support Products (LSP) | Allied Medical LLC | 12 |
| Moves | Thornhill Research Inc. | 11 |
| Ventlab | Ventlab, LLC | 7 |
| Resusa-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 7 |
| Curaplex | Bound Tree Medical, LLC | 5 |
Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202219 | 2021-02-11 |
| K162968 | 2017-04-10 |
| K073261 | 2008-05-23 |
| K041473 | 2004-07-15 |
| K001430 | 2000-07-05 |
| K973975 | 1998-06-12 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-20 | Class II | Process control | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction. | 14 cases (10 each) | 2017-10-17 |
| 2017-04-20 | Class II | Process control | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction. | 35 cases (10 each) | 2017-10-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.