Hamilton Medical announced that its reusable expiratory valves now display a unique device identification (UDI) code on the locking ring.
According to a company announcement, the addition is in line with European MDR (Medical Device Regulation) 2017/745, which requires that reusable products are marked with a UDI code if technically feasible.
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 company reports.
The code includes the following information:
- (01) GTIN code
- (10) Batch Number
- (11) Manufacturing date
- (240) Part number
| 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) |
The change does not affect the essential performance or safety of Hamilton Medical ventilators, the company says.
