日期: 06.12.2022
依据 EU MDR 2017/745,制造商有义务为不同的包装层指定一个专属的器械识别符 (UDI)。为确保符合这项法规,我们更改了我们的耗材产品线的内包装和二次包装。
内包装(最靠近产品的包装层):
二次包装(包装盒):
受影响的产品线请参见下表
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 |