---
kind: "section"
citation: "21 C.F.R. § 801.40"
title: "21"
number: "801.40"
heading: "Form of a unique device identifier."
url: "https://uscodex.org/cfr/21/801.40"
---

# §801.40. Form of a unique device identifier.

- (a) Every unique device identifier (UDI) must meet the technical requirements of [§ 830.20](/cfr/21/830.20.md) of this chapter. The UDI must be presented in two forms:
  - (1) Easily readable plain-text, and
  - (2) **Automatic identification and data capture (AIDC) technology.**
- (b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by [§ 1271.290(c)](/cfr/21/1271.290.md?p=c) of this chapter, the UDI must include a production identifier segment that conveys such information.
- (c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology.
- (d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of [subpart B](/cfr/21/subpartB.md) of this part. The UPC will serve as the unique device identifier required by [§ 801.20](/cfr/21/801.20.md).

## Notes

### Amendments

[78 FR 58818, Sept. 24, 2013]

### Authority

Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.

### Source

Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

### Amendments

[78 FR 58818, Sept. 24, 2013]