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New UDI labeling on expiratory valves 

News

Date of first publication: 05.06.2023

Our reusable expiratory valves now display the UDI on the locking ring.
New UDI labeling on expiratory valves 

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:

  • (01) GTIN code
  • (10) Batch Number
  • (11) Manufacturing date
  • (240) Part number

 
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)