Chapter 2 Nomenclature and Functions
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A label required by some countries’ regulations regarding identification of medical device
also known as Unique Device Identification.
The following information is being coded in the 2-dimensional barcode (GS1 Data Matrix);
(01) 14-digit GS1 Global Trade Item number.
(11) 6-digit date of manufacture.
(21) 8-digit serial number.
Symbol
Description Source
Catalog number ISO 15223-1
Serial number ISO 15223-1
Batch code ISO 15223-1
Date of manufacture ISO 15223-1
Manufacturer ISO 15223-1
Use-by date ISO 15223-1
Federal (USA) law restricts this device to sale by
or on the order of a physician
FDA
CE marking indicating that the device is in
conformity with the applicable requirements set
out in applicable European Union harmonization
legislation
MDR (EU)
2017/745
Temperature limit ISO 15223-1
(01) 00000000000000
(11) 000000 (21) 00000000
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