The UDI must be presented in two forms: easily readable plain-text and automatic identification and data
capture (AIDC) technology. Therefore, simply having the lot number and expiration date, for example, on
the device label will not suffice as this information is not presented as the UDI. The UDI, in the correct
format, must be on the device label as required under 21 CFR 801.40. Please see Appendix C in the
GUDID guidance document available at www.fda.gov/udi.