Marking
Assembled in Mexico
Assembled in USA
Made in USA
Unique Device Identifier (UDI)
or
The characters used in the UDI marking represent specific identifiers.
In the barcode example above:
Device identifier:
●
(01) = GS1 global trade item number (GTIN) of the device.
■
0000000000000 = Global trade item number.
■
Production identifiers:
●
(21)= GS1 application identifier for the serial number of the device.
■
XXX0000000000 = Serial number.
■
(11) = GS1 application identifier for the manufacturing date of the device.
■
000000 = Manufacturing date: year-month-day (YYMMDD).
■
Note that for some product types the production identifier can have other elements
●
instead of the ones listed above:
(10) = GS1 application identifier for the batch or lot number, followed by the
■
batch or lot number.
(17) = GS1 application identifier for the expiration date of the device, followed
■
by the expiration date.
CE marking application year
CE marking application year: 2021
5815148-01
Explanation
Country of origin Mexico.
Country of origin USA.
Unique Device Identifier. (UDI)
Every medical device has a unique marking for identification. The
UDI marking appears on the device labeling.
Note that these are only examples of UDI markings. The device may
have a linear barcode, a DataMatrix code, or only alphanumeric
identifiers with no barcode. Also, the identifiers vary per product.
Portrait
™
Mobile Monitoring Solution
Safety and intended use
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