PI stands for Production Identifier. There are five types of information that constitute PI under the rule: (1)
expiration date, (2) batch or lot number, (3) serial number, (4) manufacturing date, and (5) distinct
identification code [i.e., donor identifier for human cell tissue products (HCT/P)]. Under the rule, the PI
segment of the UDI is only required if PI appears anywhere on the device label or package (e.g., if
expiration date appears somewhere on the label, then the PI Expiration Date must be included in the UDI
for that device). Conversely, if no PIs appear on the label or package, then the UDI would only be a DI.
