M
Dear Cover's,
One of our medical device is a combination set (Foley Catheter + Syringe).
The label on the product which is packaged into one, says that the expiry of product (catheter + syringe) is 3 years. As the syringe is limited to 3 years, hence as a whole the product has a shelf life of 3 years.
However, below the expiration date we want to include a small note saying, that the catheter has 5 years of shelf life. Implying that the catheter is still safe to use once the syringe has expired.
I understand that one device, no matter how many combinations, can not have more than one expiration date. Does including the note, make it two expiration dates?
Are we breaking any regulations by doing so?
One of our medical device is a combination set (Foley Catheter + Syringe).
The label on the product which is packaged into one, says that the expiry of product (catheter + syringe) is 3 years. As the syringe is limited to 3 years, hence as a whole the product has a shelf life of 3 years.
However, below the expiration date we want to include a small note saying, that the catheter has 5 years of shelf life. Implying that the catheter is still safe to use once the syringe has expired.
I understand that one device, no matter how many combinations, can not have more than one expiration date. Does including the note, make it two expiration dates?
Are we breaking any regulations by doing so?