Basic Information
- Primary DI
- D-62617867EDP-TSLXZG
- Basic UDI-DI Code
- B-62617867EDP-TSLXZG
- Reference
- WPM2
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Ehya Darman Pishrafteh
Additional Description
EDP-TS is a life-support critical care mechanical ventilator that can provide continuous mechanical ventilation support to the patients with respiratory failure. The EDP-TS ventilator can precisely deliver a controlled mixture of oxygen and air at controlled pressure or volume into the patient’s lung and assist in the improvement of pulmonary gas exchange and oxygenation. In addition to the conventional ventilation modes, EDP-TS offers a range of modern ventilation-modes from which the user can select the one perfectly tailored to the needs of each patient. The EDP-TS ventilator runs on mains power, but it can run on the internal backup battery in case of mains power failure or intrahospital transportation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203010504 | ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | EPT0477.MDD.20/3799 | 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).