Labels - Philips EverFlo Q Service And Technical Reference Manual

8.19 LABELS

UDI Labelling
Per the Unique Device Identification (UDI) initiative, medical devices are required to be labeled with certain
device identifiers. The information provided on these labels allows the public to search and download information
from the Global Unique Device Identification Database (GUDID) at AccessGUDID.
A UDI is a unique numeric or alphanumeric code that consists of two parts:
•
a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific
version or model of a device, and
•
a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the
following when included on the label of a device:
•
the lot or batch number within which a device was manufactured;
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the serial number of a specific device;
•
the date a specific device was manufactured;
•
the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and
tissue-based product (HCT/P) regulated as a device.
Devices that are currently out in the field and manufactured before September 24
repair, return to stock, conversion, or otherwise do not need to be relabeled with UDI compliant serial/model
labeling. However, the device packaging will need to be updated to reflect UDI information.
Devices that are manufactured after September 24
converted to R/U from the base part number will not need new UDI serial/model labeling applied. However, a
new UDI number will be assigned to the corresponding R/U part number for the packaging labeling.
Serial/model labels need to be replaced with UDI compliant labeling if the label has become illegible or the repair
part where the serial label is applied requires replacement.
E :
QUIPMENT
Depending on which option is chosen, the printer used needs to ensure the barcode is legible and can be easily
scanned. When reprinting a 2D barcode, a higher resolution, 300 DPI or higher, printer may be necessary.
The following printer (or equivalent) is recommended:
Zebra GX430T or similar printer specifications:
•
Label printer
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monochrome
•
direct thermal / thermal transfer
•
Roll (4.25 in)
•
300 dpi
•
up to 240.9 inch/min
•
USB
•
LAN
•
serial
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