Pahi VersalVent
VersalVent Model V1 provides mechanical breathing support to adults undergoing prescribed therapy inside a monoplace hyperbaric chamber. It is used when respiratory failure or other…
VersalVent Model V1 provides mechanical breathing support to adults undergoing prescribed therapy inside a monoplace hyperbaric chamber. It is used when respiratory failure or other breathing requirements call for ventilation, as determined by the attending physician. Trained healthcare professionals operate it during hyperbaric treatment.
Pressurized oxygen powers the ventilator pneumatically. Its control module remains outside the chamber and connects through high pressure hoses to the patient breathing circuit inside. The operator sets inspiratory flow or volume, inspiratory and expiratory times, and the oxygen flow for intermittent mandatory ventilation.
Listed Item
The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when placed inside a monoplace hyperbaric chamber for prescribed therapy.
Pressure Compensation
A feedback hose carries chamber pressure to a differential pressure regulator. The regulator adjusts output as the chamber pressure changes to maintain the delivered tidal volume. The breathing circuit connects to a compatible disposable endotracheal tube, and a pressure relief valve limits inspiratory pressure.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 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 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Pan-America Hyperbarics, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K122560 |
| Record published | 2015-10-10 |
| Record revised | 2018-07-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Height 241.3 mm; width 203.2 mm; length 304.8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model V1 | Height 241.3 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122560 | 2013-03-26 |
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.