GE Portrait Hub01, Руководство пользователя

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Safety and intended use
Marking Explanation
Assembled in Mexico Country of origin Mexico.
Assembled in USA
Made in USA
Country of origin USA.
Unique Device Identifier (UDI)
or
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.
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
Portrait ™ Mobile Monitoring Solution
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