The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. Is Your Product a Medical Device? Determine if your product meets the definition of a device. A labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. In most instances, the labeler is the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. A unique device identifier UDI is a unique numeric or alphanumeric code that generally consists of the following:. Automatic identification and data capture AIDC : Any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.
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