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Changes to labels on packaging

News

Date of first publication: 06.12.2022

We are changing the labels on packaging for some of our consumables in accordance with the Medical Device Regulation.
Changes to labels on packaging

Pursuant to EU MDR 2017/745, manufacturers are obliged to assign a unique device identifier (UDI) to the different levels of packaging. To ensure compliance with this regulation, we have changed the primary and secondary packaging levels of our consumable lines.
 

Primary packaging level (layer of packaging closest to product):

  • QR and GTIN codes have been added (previously not displayed)
  • GTIN code starts with a 0 and equals the UDI – device identifier
     

Secondary packaging level (box):

  • GTIN code now starts with a 1 to differentiate between piece and box
  • The last digit of the GTIN has been updated to ensure an identical check sum (and thus the key’s integrity)

Affected product lines are shown below in the table below.

Label showing QR code and GTIN code
Primary packaging label
Label showing QR code and GTIN code
Primary packaging label
Label showing updated GTIN code
Secondary packaging label
Label showing updated GTIN code
Secondary packaging label

Product range

Part numbers

Breathing circuit sets for HAMILTON-H900

260161, 260186, 260185, 260187, 260200

Pressure lines

260174, 260176

Flow sensors

155500, 260177, 260179, 281637, 282049, 282051

Breathing circuit sets

260128, 260127, 260167, 260168, 260180, 260182, 260207, 260170, 260169, 260184,260240, 260241, 260244, 260087, 260094, 260145, 260144, 260257, 260206, 260239

In2Flow Nasal cannulas

10076606, 10076605, 10076604

Expiratory valve sets

160176, 161186, 161189, 950158