(UDI) Each issuing agency has its own specified format for representing the two main components of a UDI the Device Identifier (DI) and Production Identifiers (PI). The – device identifier is a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device. The production identifier is the conditional, variable portions of a UDI that identifies one or more of the following when included on the label of the device and include: lot or batch within which a device was manufactured; serial number of a specific device; expiration date of a specific device; date a specific device was manufactured; and for an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c). The format of each issuing agency’s UDI is outlined in the tables below. These issuing agencies maintain responsibility for the uniqueness of their device identifiers. Table 8: GS1 UDI Format Human Issuing Data Readable Database Agency Delimiters Identifier Data type Field Size Field Size GS1 (01) DI numeric 16 14 Manufacturing/ GS1 (11) Production Date numeric [YYMMDD] 8 6 GS1 (17) Expiration Date numeric [YYMMDD] 8 6 GS1 (10) Number alphanumeric 22 20 GS1 (21) Serial Number alphanumeric 22 20 Maximum Base UDI alphanumeric 76 66 GS1 ex: (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 Table 9: Health Industry Business Communications Council (HIBCC) UDI Format Issuing Data Identifier Data Type Human Database Agency Delimiters Readable Field Size Size HIBCC + DI alphanumeric 7 to 24 6 to 23 HIBCC $ Lot Number Only alphanumeric 19 18 HIBCC $$7 Lot Number Only alphanumeric 21 18 (alternative option) $$ Expiration Date Expiration Date: 6 4 followed by Lot numeric [MMYY] Number Lot Number: 18 18 alphanumeric HIBCC $$2 Expiration Date Expiration Date: 9 6 followed by Lot numeric [MMDDYY] Number Lot Number: 18 18 alphanumeric
(UDI) Each issuing agency has its own specified format for representing the two main components of a UDI – the Device Identifier (DI) and Production Identifiers (PI). The device identifier is a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device. The production identifier is the conditional, variable portions of a UDI that identifies one or more of the following when included on the label of the device and include: lot or batch within which a device was manufactured; serial number of a specific device; expiration date of a specific device; date a specific device was manufactured; and for an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c). The format of each issuing agency’s UDI is outlined in the tables below. These issuing agencies maintain responsibility for the uniqueness of their device identifiers. Table 8: GS1 UDI Format Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database Field Size GS1 (01) DI numeric 16 14 GS1 (11) Manufacturing/ Production Date numeric [YYMMDD] 8 6 GS1 (17) Expiration Date numeric [YYMMDD] 8 6 GS1 (10) Number alphanumeric 22 20 GS1 (21) Serial Number alphanumeric 22 20 GS1 Maximum Base UDI alphanumeric 76 66 ex: (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 Table 9: Health Industry Business Communications Council (HIBCC) UDI Format Issuing Agency Data Delimiters Identifier Data Type Human Readable Field Size Database Size HIBCC + DI alphanumeric 7 to 24 6 to 23 HIBCC $ Lot Number Only alphanumeric 19 18 HIBCC $$7 Lot Number Only (alternative option) alphanumeric 21 18 $$ Expiration Date followed by Lot Number Expiration Date: numeric [MMYY] 6 4 Lot Number: alphanumeric 18 18 HIBCC $$2 Expiration Date followed by Lot Number Expiration Date: numeric [MMDDYY] 9 6 Lot Number: alphanumeric 18 18
CDAR2_IG_PACP_R1_DSTU1.0_2015NOV_Vol1_Introductory_Material20150922.docx