Equipment Identification - GE HEALTHCARE CARESCAPE Monitor B650 Technical Manual

CAUTION DISPOSAL - At the end of its service life, the product described in this manual,
as well as its accessories, must be disposed of in compliance with the
guidelines regulating the disposal of each product. If you have any questions
concerning disposal of a product, please contact GE or its representatives.

3.4.2 Equipment identification

Unique Device Identifier (UDI)
Every medical device has a unique marking for identification. The UDI marking appears on the
device labeling The characters used in the UDI marking represent specific identifiers.
In the example above:
Device identifier:
•
(01) = GS1 global trade item number (GTIN) of the device.
•
1234567891234 = Global trade item number.
Production identifiers:
•
(21) = GS1 application identifier for the serial number of the device.
•
SK412345678HA = Serial number, where the first three characters represent Product
Code.
•
(11) = GS1 application identifier for the manufacturing date of the device.
•
151228 = 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.
Device label
Every GE device has a unique serial number for identification. The serial number is written in a
device label. A sample of the information on a device label is shown below. The product code
for CARESCAPE Monitor B650-02 is SK4.
System overview
21
2081903-001