Lot or batch

In the US, the lot or batch is the unit that UDI production identifiers, labeling and recalls often refer to. Defining lots clearly in production records makes it possible to find and act on every affected unit when a problem shows up.

Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

21 CFR, 801.3

Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

21 CFR, 830.3