Class II Disposable Medical Device Label Content Requirements

[dwayneq]

Forgive me if this has been covered already. I did some searching but didn't see an appropriate answer. We have a class II plastic kit assembly this is minimally invasive. Currently we have the following items covered: company name, product description, catalog number, quantity included, manufacturing company address, lot identification, manufacture date, expiration date, use requires prescription, protect from liquids, latex free, xxx, xxx, sterile by EO, see user manual, label part number, and UDI barcode.

On durable equipment and electromechanical parts used on durable equipment we also list operating conditions as well as storage and shipping conditions. I don't believe that this information is required on these sterile sealed plastic components but I have been questioned on this. I have not found anything so far that points me one way or another. Can anyone point me to label requirements that would help clear this up?

Thank you, Dwayne

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[maaquilino]

As I'm not sure what the device is, and you mentioned it's minimally invasive, I can't give very specific info, but the links below may help.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf

Several links here, including the one above:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/devicelabeling/default.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=801

http://www.fda.gov/MedicalDevices/D...temRegulationLabelingRequirements/default.htm

 

[dwayneq]

Thank you maaquilino for posting these links. However, I found all of these with a Google search and none really stated anything regarding shipping, storage or use label requirements unless the performance of the device is affected. Anyone else who manufactures disposables like blood tubing sets or filters have anything to share?