The US Food and Drug Administration (FDA) has designated the Health Industry Business Communications Council (HIBCC) as an Issuing Agency as part of the requirements of its Unique Device Identification (UDI) regulation of medical devices
HIBCC UDI Decoder
What is it about?
The US Food and Drug Administration (FDA) has designated the Health Industry Business Communications Council (HIBCC) as an Issuing Agency as part of the requirements of its Unique Device Identification (UDI) regulation of medical devices. This application has been created as a tool to decode valid HIBC auto-Identification symbols and identify the FDA-specified UDI components. Although it will quickly identify all the elements that comprise HIBC symbols, it is not intended to replace the more rigorous verification processes available to labelers who create and print them on packaging and labels.
App Screenshots
App Store Description
The US Food and Drug Administration (FDA) has designated the Health Industry Business Communications Council (HIBCC) as an Issuing Agency as part of the requirements of its Unique Device Identification (UDI) regulation of medical devices. This application has been created as a tool to decode valid HIBC auto-Identification symbols and identify the FDA-specified UDI components. Although it will quickly identify all the elements that comprise HIBC symbols, it is not intended to replace the more rigorous verification processes available to labelers who create and print them on packaging and labels.
HIBCC® is an internationally recognized and accredited standards development organization that maintains the Health Industry Bar Code and Auto Identification labeling standard. This standard uniquely meets the needs of medical device labelers by providing an alphanumeric, variable length labeling format which allows direct placement of product codes into auto identification symbols. Direct placement eliminates the need for risky cross-referencing found in the more limited “numeric-only” formats that were designed for common retail products. Alphanumeric codes thus enhance security, accuracy and reliability, and are used in those industry supply chains where consumer safety and sensitivity to errors are critical and necessary. Healthcare companies that label using the HIBCC standard are demonstrating their commitment to patient safety and best practices.
The HIBCC standard is accredited by the American National Standards Institute (ANSI) and the European Committee for Standardization (CEN) and is recognized by the International Standards Organization (ISO).
Supports all symbologies that are recommended in the HIBC standard.
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