I have a question regarding UDI labeling and external power modules. If I have a medical device that uses an external power module (60601-1 approved, DC output) for power and the module is essentially off the shelf (has different connector than standard), does it need UDI labeling on the module for the module?
For the product labeling on the module itself, would the MANUFACTURER (contact info, etc) be the company that makes the supply module or would it be the company that then provides the module with the medical device for which it is being used?
For the product labeling on the module itself, would the MANUFACTURER (contact info, etc) be the company that makes the supply module or would it be the company that then provides the module with the medical device for which it is being used?