Shipping container

Under the FDA UDI rules, shipping containers are not device packages, so they do not need a UDI. The reason is that their contents vary, unlike a device package with a fixed quantity.

Shipping container means a container used during the shipment or transportation of devices, and whose contents may vary from one shipment to another.

21 CFR, 801.3

Shipping container means a container used during the shipment or transportation of devices, and whose contents may vary from one shipment to another.

21 CFR, 830.3