UDI

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of:
(1) A device identifier - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
(2) A production identifier - a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.
(v) For an HCT/P regulated as a device, the distinct identification code required by ยง 1271.290(c) of this chapter.

Source

21 CFR § 821.3


Scoping language

The following definitions and terms apply to this part:

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