FDA许可的发行机构UDI格式

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FDA在2015年11月3日发布了三家其许可的作为发行机构的组织的UDI格式的文件，该三家组织分别为GS1、Health Industry Business Communications Council（HIBCC）和International Council for Commonality in Blood Banking Automation（ICCBBA）。该文包括每家FDA许可的发行机构的UDI格式相关的信息和链接，每家发行机构在其最初的许可过程中都有其独特的FDA许可的UDI格式。发行机构的UDI格式的任何变化在实施前都必须经FDA批准。如果您要获得一个UDI，以及咨询关于其格式的创建或实现的任何其他问题，请直接联系发行机构。

FDA正在与发行机构和其他利益相关机构一起制定一个变更控制计划，本文的下一个版本将包括这个计划。

各发行机构的UDI格式如下表所示：

表1：GSI发行机构的UDI格式

发行机构	数据分隔符	标识符	数据类型	人类可读的字段长度	数据库字段长度
GSI	(01)	DI	Numeric	16	14
GSI	(11)	Manufacturing/ Production Date	numeric [YYMMDD]	8	6
GSI	(17)	Expiration Date	numeric [YYMMDD]	8	6
GSI	(10)	Batch/Lot Number	alphanumeric	22	20
GSI	(21)	Serial Number	alphanumeric	22	20
GSI		Maximum Base UDI	alphanumeric	76	66
举例: (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234

表2：Health Industry Business Communications Council® (HIBCC) Issuing Agency的UDI格式

发行机构	数据分隔符	标识符	数据类型	人类可读的字段长度	数据库字段长度
HIBCC	+	DI	Alphanumeric	7 to 24	6 to 23
HIBCC	$	Lot Number Only	Alphanumeric	19	18
HIBCC	$$7	Lot Number Only (alternative option)	Alphanumeric	21	18
HIBCC	$$	Expiration Date followed by Lot Number	Exp Date: numeric [MMYY]	6	4
HIBCC	$$	Expiration Date followed by Lot Number	Lot Number: alphanumeric	18	18
HIBCC	$$3	Expiration Date followed by Lot Number	Exp Date: numeric [YYMMDD]	9	6
HIBCC	$$3	Expiration Date followed by Lot Number	Lot Number: alphanumeric	18	18
HIBCC	$$4	Expiration Date followed by Lot Number	Exp Date: numeric [YYMMDDHH]	11	8
HIBCC	$$4	Expiration Date followed by Lot Number	Lot Number: alphanumeric	18	18
HIBCC	$$5	Expiration Date followed by Lot Number	Exp Date: numeric [YYJJJ] – Julian Date format	8	5
HIBCC	$$5	Expiration Date followed by Lot Number	Lot Number: alphanumeric	18	18
HIBCC	$$6	Expiration Date followed by Lot Number	Exp Date: numeric [YYJJJHH] – Julian Date format with Hour option	10	7
HIBCC	$$6	Expiration Date followed by Lot Number	Lot Number: alphanumeric	18	18
HIBCC	$+	Serial Number only	Alphanumeric	20	18
HIBCC	$$+7	Serial Number only (alternative option)	Alphanumeric	22	18
HIBCC	$$+	Expiration Date followed by Serial Number	Exp Date: numeric [MMYY]	7	4
HIBCC	$$+	Expiration Date followed by Serial Number	Serial Number: alphanumeric	18	18
HIBCC	$$+2	Expiration Date followed by Serial Number	Exp Date: numeric [MMDDYY]	10	6
HIBCC	$$+2	Expiration Date followed by Serial Number	Serial Number: alphanumeric	18	18
HIBCC	$$+3	Expiration Date followed by Serial Number	Exp Date: numeric [YYMMDD]	10	6
HIBCC	$$+3	Expiration Date followed by Serial Number	Serial Number: alphanumeric	18	18
HIBCC	$$+4	Expiration Date followed by Serial Number	Exp Date: numeric [YYMMDDHH]	12	8
			Serial Number: alphanumeric	18	18
HIBCC	$$+5	Expiration Date followed by Serial Number	Exp Date: numeric [YYJJJ]	9	5
HIBCC	$$+5	Expiration Date followed by Serial Number	Serial Number: alphanumeric	18	18
HIBCC	$$+6	Expiration Date followed by Serial Number	Exp Date: numeric [YYJJJHH]	11	7
HIBCC	$$+6	Expiration Date followed by Serial Number	Serial Number: alphanumeric	18	18
HIBCC	/S	Supplemental Serial Number, where lot number also required and included in main secondary data string	Alphanumeric	20	18
HIBCC	/16D	Manufacturing Date (supplemental to secondary barcode)	numeric [YYYYMMDD]	12	8
HIBCC	/14D	Expiration Date (supplemental to secondary barcode)	Numeric [YYYYMMDD]	12	8
HIBCC	Maximum Base UDI	Alphanumeric	70 to 87	58 to 75	HIBCC
人类可读的条形码举例：+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C

表3：International Council for Commonality in Blood Banking Automation (ICCBBA) Issuing Agency

发行机构	数据分隔符	标识符	数据类型	人类可读的字段长度	数据库字段长度
ICCBBA	=/	DI	Alphanumeric	18	16
ICCBBA	=,	Serial Number	Alphanumeric	8	6
ICCBBA	=	Donation Identification Number	Alphanumeric	16	15
ICCBBA	=>	Expiration Date	numeric [YYYJJJ]	8	6
ICCBBA	=}	Manufacturing Date	numeric [YYYJJJ]	8	6
ICCBBA	&,1	MPHO Lot Number	Alphanumeric	21	18
ICCBBA	Maximum Base UDI for HCT/Ps	Alphanumeric	79	67	ICCBBA
人类可读的条形码举例： =/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123

仅适用于血袋	数据分隔符	标识符	数据类型	人类可读的字段长度	数据库字段长度
ICCBBA	=)	DI for blood containers (bags)	Alphanumeric	12	10
ICCBBA	&)	Lot Number for blood containers (bags)	Alphanumeric	12	10
ICCBBA	Maximum Base UDI for Blood Bags	Alphanumeric	24	20	ICCBBA
人类可读的条形码举例：=)1TE123456A&)RZ12345678

来源：网络