Date of first publication: 05.06.2023
The European MDR (Medical Device Regulation) 2017/745 requires that reusable products are marked with a UDI (unique device identification) code if technically feasible. For this reason, we are now implementing the UDI code on our reusable expiratory valves (see product details below). The code is being added by laser marking to the locking ring of the expiratory valves as a data matrix code (machine readable), as well as in an HRI (human readable interpretation) format.
The code includes the following information:
Please note that this change does not affect the essential performance or safety of Hamilton Medical ventilators.
| PN | Description |
|---|---|
| PN 160245 | Expiratory valve for HAMILTON-C2/C3/C6 Adult/Pediatric/Neonatal (Rev. 07) |
| PN 161175 | Expiratory valve for HAMILTON-C1/T1/MR1 Adult/Pediatric (Rev. 07) |
| PN 161188 | Expiratory valve for HAMILTON-C1/T1/MR1 Neonatal (Rev. 06) |