CARevent CPAP
The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient…
The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient circuit with facemask, head harness and airway pressure gauge make application and operation of the O-Two CAREvent CPAP extremely simple for the rescuer and more comfortable and less distressing for the patient.
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) | K093862 |
| Record published | 2016-02-03 |
| 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 temperature -40 to 60 °C |
| Sizes | Weight 0.45 kg; height 2.9 in; width 2.5 in; length 5.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01CV0200-1 | Weight 0.45 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
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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.