O_two E500
The o_two e500 is an emergency and transport ventilator for patients in respiratory distress or respiratory or cardiac arrest. It delivers time-cycled, volume-constant ventilation for…
The o_two e500 is an emergency and transport ventilator for patients in respiratory distress or respiratory or cardiac arrest. It delivers time-cycled, volume-constant ventilation for adults, children and infants requiring tidal volumes of at least 100 mL.
The ventilator is electronically controlled and pneumatically powered. An AC/DC adapter or internal rechargeable lithium-ion battery supplies its electronics, while a color screen displays ventilation values, waveforms, settings and status.
Listed Item
o_two e500 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery pack used to power the electronics, intended for use during transport to provide resuscitation and/or ventilatory support to wide range of patients in respiratory distress or arrest. It is a time-cycled, volume-constant and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 100 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support.
Monitoring and Transport
Visual and audible alarms alert the healthcare professional to changes in patient or device parameters. The system is intended for prehospital, hospital and interhospital use and ground transport. Pressure-controlled ventilation is a feature of the separate e700 model, rather than the e500.
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 | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K141595 |
| Record published | 2015-10-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -40 to 60 °C |
| Sizes | Length 200 to 250 mm; weight 2.4 kg; height 155 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01EVE500 | Weight 2.4 kg | 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 |
|---|---|
| K141595 | 2015-03-16 |
| K093862 | 2010-05-06 |
| K081330 | 2009-03-06 |
| K051469 | 2005-09-28 |
| K051889 | 2005-08-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| O-TWO Medical Technologies, Inc. | 510(k) number | 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 136 | 2023-06-29 |
| O-TWO Medical Technologies, Inc. | 510(k) number | 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 119 | 2023-06-29 |
| O-TWO Medical Technologies, Inc. | 510(k) number | 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 632 | 2023-06-29 |
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.