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
(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
Universal product code (UPC) means the product identifier used to identify an item sold at retail in
Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that require use of a new device identifier.
830.60 Relabeling of a device that is required to bear a unique device identifier.
A unique device identifier (UDI) must:
(a) Be issued under a system operated by
(b) Conform to each of the following international standards:
(1) ISO/IEC 15459-2, which is incorporated by reference at
(2) ISO/IEC 15459-4, which is incorporated by reference at
(3) ISO/IEC 15459-6, which is incorporated by reference at
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at
(a) Only one device identifier from any particular system for the issuance of unique device identifiers (UDIs) may be used to identify a particular version or model of a device. A particular version or model may be identified by UDIs from two or more systems for the issuance of UDIs.
(b) A device identifier shall be used to identify only one version or model.
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