UDI Guidelines
CUSTOMER BULLETIN
Ferno Product Label Changes
In order to continually improve the standards of Ferno, some of our products will
now be serialized and labeled according to GS1 standards and the FDA Unique
Identification regulation “UDI”.
New Labeling Ensures Best Practices
Unique Device Identification (UDI)
Ferno is updating product labels to include
barcodes that conform to specifications
created by GS1, a company that develops
and maintains standards for supply and
demand chains for multiple industries,
including healthcare. GS1 gives us a
common language to identify, capture
and share supply chain data—ensuring
important information is accessible,
accurate and easy-to-understand.
Changes to Ferno Labels
Soon, you will see GS1 DataMatrix (2D)
barcodes on some of Ferno’s products.
In the later future, a product’s unique
identifier, or Global Trade Item Number
(GTIN), will also be added to packing
slips, invoices and other documents.
If product barcodes are used in your
current inventory tracking system, or in
the patient care process, your barcode
• The UDI system will provide a consistent and
standard way to identify medical devices, sold
in the U.S., throughout their distribution and
use by healthcare providers and patients.
• A UDI is composed of two parts: Device
Identifier (DI) + Production ldentifier(s) (Pl)
• A unique device identifier (UDI) on a device
label appears in both plain text and in
machine-readable format.
• Most devices will be required to have a UDI
on their label and packaging, and for certain
devices, on the product itself.
• Device companies must submit certain
information about their devices to the Global
Unique Device Identification Database (GUDID).
• The AccessGUDID portal was created to make
device identification information in the GUDID
database available to the public.
Visit www.accessgudid.nlm.nih.gov for information.
Future Barcode
scanning system may need to be updated
to recognize GS1 DataMatrix 2D barcodes.
For more information about UDI, Ferno’s
transition to new product labels, and GS1
DataMatrix 2D barcodes, please call us at
877.733.0911.
FERNOEMS .COM | 8 77.733.0911