§830.20. Requirements for a unique device identifier. — Inbound Citations

(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.

Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

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

Specification means any requirement with which a device must conform.

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:

(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter. The UDI must be presented in two forms:

(1) Easily readable plain-text, and

(bb) 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 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 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;

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

(n) 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 UDI is composed of:

(1) 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 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;

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

(m) 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 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 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;

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

(q) 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 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 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;

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

(o) 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 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 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;

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

(o) 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 UDI is composed of:

(1) 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 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;

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

(a) Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of § 830.20;

(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.

Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

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

Small business means a medical device manufacturer with 500 or fewer employees, or a medical device relabeler or repackager with 100 or fewer employees.

Specification means any requirement with which a device must conform.

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20. A UDI is composed of:

(1) The device identifier submitted does not conform to § 830.20;

(2) 2006(E), Information technology—Unique identifiers—Part 2: Registration procedures (second edition; March 1, 2006), into §§ 830.20(b) and 830.100(b);

(1) 1991(E), Information technology—ISO 7-bit coded character set for information interchange (third edition; December 15, 1991), into §§ 830.20(c) and 830.100(b);