DEVICE DETAILS
| NAME OF DEVICE | QTUBE BREATHING CIRCUIT |
|---|---|
| ESTABLISHMENT NAME | AARGYP SCIENTIFIC SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB10703819-29150 |
| BRAND NAME | ENVISEN |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Breathing Circuits which are disposable and generally recommended for Single Use when supplied as is. A breathing circuit transfers gas and air mixtures from the anaesthetic machine/ventilator to the patient to ensure they remain under anaesthetic and suitably perfused with oxygen and from the patient to the anaesthetic machine/ventilator to ensure entidal carbon dioxide levels are drawn off from the patient at the same time. Standard corrugated circuits have a high turbulent effect or gas flow through the tube, which in turn creates high flow resistance. This is why a standard circle breathing circuit has two large tubes, inspiratory and expiratory to keep resistance to an acceptable level. The Qtube™ incorporates a smooth, bilumen inner wall design, which significantly improves internal flow and breathing resistance. The Qtube has been designed as single, small, low volume tube. |
| DEVICE INTENDED PURPOSE | A breathing circuit transfers gas and air mixtures from the anesthetic machine/ventilator to the patient to ensure they remain under anesthetic and suitably perfuse with oxygen and from the patient to the anesthetic machine/ventilator to ensure entidal carbon dioxide levels are drawn off from the patient at the same time. |
| VALIDITY DATE OF REGISTRATION | 04/06/2024 - 03/06/2029 |