§1271.290. Tracking. — Inbound Citations

(c) Procedures must ensure that each HCT/P is labeled in accordance with all applicable labeling requirements, including those in §§ 1271.55, 1271.60, 1271.65, 1271.90, 1271.290, and 1271.370, and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under § 1271.55.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States.

Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler.

(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) of this chapter, the UDI must include a production identifier segment that conveys such information.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States.

Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler.

(1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);

(B) (1) The lot or batch within which a device was manufactured;

(2) The serial number of a specific device;

(3) The expiration date of a specific device;

(4) The date a specific device was manufactured; and

(5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c).