Basic Information
- Primary DI
- 06261786700025
- Basic UDI-DI Code
- B-06261786700025
- Reference
- WPM1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Ehya Darman Pishrafteh
Additional Description
Anesthesia machine is a pneumatic driven and electronically controlled anesthesia ventilator intended for anesthesia ventilation for all patient groups (infant to adult). The device is based on the horizontal bag-in-bottle system. It provides a separate inspiratory and expiratory path controlled by 2 one-way valves: the inspiratory valve and the expiratory valve. Both circuits join together in a Y-piece and connect to the patient's endotracheal tube. The other end of the circuit is connected to either a manual balloon for manual ventilation or to the internal bag-in-bottle for automatic ventilation modes, like CMV, SIMV, and PCV.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203010101 | ANAESTHESIA DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | EPT0477.MDD.20/3798 | Eurofins Product Testing Italy S.r.l. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).