Device package

Each level of packaging with a fixed quantity gets its own UDI-DI under the US UDI rule. Changing the quantity in a package means a new device identifier.

Device package means a package that contains a fixed quantity of a particular version or model of a device.

21 CFR, 801.3

Device package means a package that contains a fixed quantity of a particular version or model of a device.

21 CFR, 830.3