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in 2013 the US Food and Drug Administration was mandated to implement regulations requiring that medical devices distributed in the United States bear a unique device identifier known as UDI a UDI consists of two parts a device identifier and a production identifier the DI portion of a UDI is used to identify the device type device identifiers are provided by an FDA accredited issuing agency the P AI portion of a UDI identifies a devices production information such as its batch number or its expiration date if a company manufactures multiple batches of the same device the DI for each batch will be the same but the P AI will be different UTIs must be included on a device labeling and must be displayed in human readable and machine readable format if the device is intended to be used more than once and intended to be reprocessed before each use the UDI must also be placed on the device itself device labelers are responsible for complying with FDAs new UDI requirements FDA defines a de