Unique Device Identification FAQ

Understanding the UDI initiative

What is a UDI?
What is a UDI?
The US FDA Unique Device Identifier (UDI) Final Rule establishes a system to identify medical devices throughout their distribution and use, including hospitals and patients.

The UDI is a set of alphanumeric codes consisting of a Device Identifier “DI” (company and product code) and a Production Identifier “PI” (specific manufacturing information). Most UDI labels will include both machine-readable (e.g. barcode, radio-frequency identification) and human-readable (HRI) formats.

The UDI is submitted to the FDA Global Unique Device Identification Database (AccessGUDID) to help the public identify their medical device.

How will this impact Philips products?

In accordance with the UDI Final Rule from FDA, the UDI is required to appear on the device label and package label of a medical device. The UDI is composed of two parts, the Device Identifier (DI) and the Production Identifier (PI).

UDI Unique Device Identification	GS1 Standards Product Identification
DI Device Identifier (DI)	GTIN Global Trade Item Number (01)
PI Production Identifier (PI)	AI Application Identifier (AI) Manufacturing Date AI(11) - e.g. 160924 Expiration Date AI(17) - e.g. 171224 Lot/Batch AI(10) - e.g. 1234AB Serial Number AI(21) - e.g. 1234xyz Date formats within GS1 UDIs are always in the format YYMMDD, where YY=year, MM=month, DD=date.

Production Identifier data will vary by medical device type and manufacturer current practice.

DI + PI = UDI

GTIN or GTIN + AI(s) = UDI

Do I need to make any changes due to UDI?
Do I need to make any changes due to UDI?
Adoption of UDI will allow healthcare providers to use UDI data in their procurement systems, inventory management systems, electronic health record systems and implant registries. These systems may need to be modified to accept certain UDI fields such as the 14-digit GTIN device identifier (DI), and new date format (YYYY-MM-DD).
Why did the FDA start the UDI initiative?
Why did the FDA start the UDI initiative?
FDA believes the UDI system will make it possible to identify a device and key attributes that affect its safe and effective use. Additionally, the UDI system will facilitate healthcare product data synchronization and accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. Synchronizing healthcare product data allows the healthcare industry to know when and where products are produced and to manage recall and adverse event reporting to a global standard.

The FDA website explains the UDI rule, the GUDID data elements and other relevant information: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

The FDA published a set of FAQs that may also be helpful: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf
What are the benefits noted by the FDA once a UDI system is fully implemented?
What are the benefits noted by the FDA once a UDI system is fully implemented?
The FDA notes the following benefits may emerge after the system is fully implemented:

Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.

Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.

Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.

Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
Is UDI truly a 'unique' identifier?
Is UDI truly a 'unique' identifier?
No, for products that do not have a production identifier or are Batch/lot/manufacture date controlled (or in other words, do not use serial numbers), the UDI number will be the same for these medical devices.

Is Philips required to comply with the FDA requirement for the UDI rule?

Yes. The FDA has established a specific timeline for medical device compliance. Class III devices were the first group of devices that must comply, followed by Class II Life Supporting/Life Sustaining, Class II and Class I. If these dates are not met, the product cannot be distributed in the U.S.
If a Philips product is required to be direct marked, the compliance dates are extended by 2 years.

	Final Rule	Sept 24, 2014	Sept 24, 2015	Sept 24, 2016	Sept 24, 2018
Labels and packages must contain UDI Dates must be formatted by YYYY-MM-DD Products must be submitted to FDA UDI Database	Final rule Published Sept. 24, 2013	Class III	Implantable or Life Sustaining/ Supporting	Class II	Class I

How is the new UDI being used?
How is the new UDI being used?
The FDA requires medical device labelers, like Philips, to include a unique device identifier (UDI) on device labels and packages except where the UDI Final rule provides for an exception or alternative. The UDI will stay with the product from the time of manufacture to its end of life and can be added to patients’ Electronic Health Records (EHRs) and healthcare claim forms.
What Philips devices are affected by this regulation?
What Philips devices are affected by this regulation?
Philips distributes US FDA Class III, Class II Life Support/life sustaining, Class II and Class I devices and is working to ensure they comply with the UDI regulation.
When can I expect to see UDIs on Philips products?
When can I expect to see UDIs on Philips products?
Philips introduced UDI on its Class III products in September 2014. UDI labels on Class II Life Supporting/Life Sustaining products were introduced in 2015. By the end of September 2018, we will have our entire product family labeled with UDI. During the transition period, you will see a mixed inventory of products as our supply chain pipeline is depleted. There is no difference between products that have no UDI label, or are HIBCC or GS1 labeled.
Must other Medical Device Manufacturers comply with the FDA Requirements?
Must other Medical Device Manufacturers comply with the FDA Requirements?
Yes. The timeline is the same for all manufacturers.
How does this impact healthcare providers with Philips products?
How does this impact healthcare providers with Philips products?
For healthcare providers that scan product label bar codes, their Materials Management Information System (MMIS) will need to be updated to either add the new GTIN barcode in addition to the existing UPC/HIBCC/NHRIC barcodes or replace the UPC part numbers with the new GTIN part numbers (if their MMIS cannot accommodate dual part numbers).

Labeling and barcoding

How does the UDI differ from production device identification information (serial number, lot, etc.) that was previously on the label?
How does the UDI differ from production device identification information (serial number, lot, etc.) that was previously on the label?
Philips has always shipped product with a unique serial number and when appropriate a lot/batch number, expiration date, manufacture date and/or install-by date. This is how we identify a device and use this information for Quality and Regulatory needs in addition to guiding our service and support. All of this information is still present on your labeling.

What is the timeline for Philips to comply with the UDI FDA Requirements?

UDI labeling began in 2014. Each month additional products will transition to the new label format.
As part of the Final UDI Rule, FDA granted an exception for manufacturers existing inventory. Over the next 3 years, you will see a mixed inventory of products as our existing inventory is depleted. There is no difference between products that have no UDI label, or are HIBCC or GS1 labeled.
This exception also applies to products consigned to a hospital or potential purchaser but not yet purchased.

	Final Rule	Sept 24, 2014	Sept 24, 2015	Sept 24, 2016	Sept 24, 2018
Labels and packages must contain UDI Dates must be formatted by YYYY-MM-DD Products must be submitted to FDA UDI Database	Final rule Published Sept. 24, 2013	Class III	Implantable or Life Sustaining/ Supporting	Class II	Class I

Do I need to return inventory that doesn't have the new UDI labeling?
Do I need to return inventory that doesn't have the new UDI labeling?
No. Products manufactured after the UDI dates will be labeled with GS1 barcodes; however, there still may be product in inventory that may have no UDI number or have a HIBCC label. Per the FDA timeline, Philips will have three years from each specific implementation deadline to deplete its inventory. There is no requirement to relabel devices that are already at customer sites.
Where can I find the UDI labeling on my Philips Medical Device?
Where can I find the UDI labeling on my Philips Medical Device?
UDI compliant labeling must appear on the medical device itself. This may be on an applied device label.

UDI compliant labeling must appear on the primary packaging of a medical device. This includes cardboard cartons or bag labels.

If the medical device requires reprocessing or sterilization between uses, the UDI may also be direct marked on the medical device (e.g. laser etched).
Where can I find the UDI on my Software Medical Device?
Where can I find the UDI on my Software Medical Device?
For Stand-alone software, the UDI in the human readable format will be displayed on the ‘About’ or splash screens in the software. This does not include embedded or system software.
Why don't all the accessories I purchase have UDIs?
Why don't all the accessories I purchase have UDIs?
Accessories that are intended to support, supplement, and/or augment the performance of one or more parent devices will have a UDI.

Accessories that do not meet this definition, are considered to be exempt from the UDI rule.
Why are there different UDI numbers on a product?
Why are there different UDI numbers on a product?
In order to adequately identify a device throughout distribution and use, each packaging level (box of 10, 20, 30, etc.) must have a UDI.

** Note: Image Source: GS1 Healthcare GTIN Allocation Rules; GTIN Allocation Rules for the Healthcare Sector release 9.0.2, Ratified, Dec 2015.
Why does my kit have a UDI that is different that the products in it?
Why does my kit have a UDI that is different that the products in it?
Each medical device in a kit is required to bear a UDI. If each medical device has a UDI, then it is not required to label the medical devices with the UDI of the Kit.
Why doesn't my rental or loaner have a UDI?
Why doesn't my rental or loaner have a UDI?
If a medical device was manufactured before it’s FDA compliance date, it does not require a UDI.
What is the layout/format for the barcode?
What is the layout/format for the barcode?
For the machine-readable component of the UDI, Philips uses the GS1-128 barcode 1D Linear barcode or the GS1 DataMatrix 2D barcode. The data contained within the GS1 barcode is encoded using Application Identifiers (AIs) to separate the individual parameters.

The Human Readable Interpretation (HRI) component of the UDI will appear next to the 2D barcode with each parameter prefixed by its AI in parentheses "(xx)“.
What will the new product labels look like?
What will the new product labels look like?
The new label features the addition of the UDI number which consists of the Global Trade Item Number (GTIN) device identifier (DI) and the production identifiers (PI’s) in both human readable and bar code format.
Do all medical devices need to be direct marked with their UDI?
Do all medical devices need to be direct marked with their UDI?
No. The rule only requires direct marking for re-usable medical devices that need to be reprocessed/sterilized before reuse.
Are other medical device manufacturers using these GS1 standards?
Are other medical device manufacturers using these GS1 standards?
Yes. Most major medical device manufacturers across the healthcare industry have adopted GS1 standards.

FDA has accredited 3 organizations as UDI issuing agencies:

- GS1,

- Health Industry Business Communications Council (HIBCC), and

- International Council for Commonality in Blood Banking Automation (ICCBBA).

Each issuing agency has its own UDI format that was reviewed and approved by FDA.
Do I have to use the new UDI barcode?
Do I have to use the new UDI barcode?
No. All Philips labels will continue to have the same information they had before. The UDI labeling (2D barcode or 1D barcode and the Human Readable Interpretation) is additional information.
What is the differences between the barcodes?
What is the differences between the barcodes?
A 1D (linear) organizes information horizontally from left to right. This can be read by any type of barcode scanner. 2D barcodes organize information vertically and horizontally. This allows 2D codes to hold more information and take up less space than a 1D code. However, a 2D codes require an imager scanner to be read properly.
Why do we have this new barcode, and how can I use it?
Why do we have this new barcode, and how can I use it?
It is a new FDA regulation that all medical devices for distribution in the US be labeled with a UDI. Production Information such as a serial number, expiration date, manufacture date, and/or batch number is contained in the new barcode, as applicable when used for tracing product. Most barcode scanners will automatically decode GS1 compliant barcodes. Find out more about the GS1 Standards.
Can I use my current scanner for the new 2D barcode?
Can I use my current scanner for the new 2D barcode?
2D barcodes require a 2D imager. The data stored in a 2D barcode runs both horizontally and vertically, so only an imager (2D barcode scanner) can properly decode the information. A 1D barcode scanner will not be able to read a 2D barcode; however, a 2D barcode scanner can read a 1D barcode.
How do I program my scanner for this new barcode
How do I program my scanner for this new barcode
Please ensure you have a 2D barcode scanner. This scanner contains an imager that is necessary for scanning 2D barcodes. Most barcode scanners will automatically decode GS1 compliant barcodes. If you are uncertain if your barcode scanner is GS1 capable, contact your barcode scanner supplier.
What if some of my Philips products have HIBCC barcodes?
What if some of my Philips products have HIBCC barcodes?
All products manufactured after the UDI compliance dates provided by the FDA will have GS1 barcodes in addition to other barcodes you are used to seeing. Per the FDA timeline, Philips will have three years from each specific implementation deadline to deplete its inventory.

GS1, GDSN, GLN, GTIN, GMDN & GUDID

What are all these acronyms?
What are all these acronyms?
GS1: The GS1 General Specifications is the core standards document of the GS1 System describing how GS1 bar codes and identification keys should be used.

GTIN: Global Trade Item Number - The GTIN is a globally unique 14-digit number used to identify trade items, products, or services.

GUDID: The FDA Global Unique Device Identification Database (GUDID) is a publically accessible database that will serve as a reference catalog for every device with an identifier intended for the US market and manufactured after the relevant compliance date.

GDSN: The Global Data Synchronization Network (GDSN) is an internet-based, interconnected network of data pools and a global registry known as the GS1 Global Registry, that enables companies around the globe to exchange standardized and synchronized data elements for products/parts assigned GTIN numbers.

GLN: Global Location Number – The GLN is part of the GS1 systems of standards and is used primarily in electronic messages to identify companies legal and physical locations.
What are the GS1 Standards?
What are the GS1 Standards?
GS1 supply chain standards are the most widely standards system in the world. The GS1 Standards are used globally by manufacturing companies to ensure data captured from GS1 barcodes are unambiguous, and can electronically communicate this data to inventory management systems.

GS1 uses a Global Trade Identification Number (GTIN) that uniquely identifies devices that are traded in the healthcare supply chain. The GTIN identifies a products Device Identifier (DI) and associated Production Identifier(s) (PI) when scanned.

To learn more about GS1 Healthcare, please visit www.gs1.org/healthcare.

- GS1 AIDC Healthcare Guideline http://www.gs1.org/docs/healthcare/GS1_Healthcare_Implementation_Guideline.pdf

- Use of GS1 2D / Matrix Data Carriers in Healthcare http://www.gs1.org/sites/default/files/docs/healthcare/gs1_hc_2d_data_carrier_use_position_-_20160501_final.pdf
What is GMDN?
What is GMDN?
The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices. It is used by regulators, hospitals and manufacturers to identify medical devices that are of the same generic type. This supports market surveillance, adverse event reporting, product recall and other healthcare management activities.

The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. The following is an example:

- GMDN Term Name - "Scalpel, single-use"

- GMDN Code - "47569"

- GMDN Definition - "A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device."
What is GTIN?
What is GTIN?
A GTIN (Global Trade Item Number) is a globally unique identification number of an item in the supply chain that identifies a product from manufacturing through distribution and use. The GS1 GTIN is typically a 14-digit numeric code which includes a company prefix. The GTIN, as well as other key product attributes (Production Identifiers), are automatically identified when a bar code is scanned.
Where will I see the GTIN?
Where will I see the GTIN?
GTINs are used on product and packaging labeling.
Where will I see the GTIN for stand-alone software?
Where will I see the GTIN for stand-alone software?
GTINs are also found on the Stand-alone software ‘About’ or splash screens.
Is the GTIN replacing the HIBCC numbers and barcodes on all current products?
Is the GTIN replacing the HIBCC numbers and barcodes on all current products?
Philips is transitioning over to the GS1 standards. The Global Trade Item Number (GTIN) will now be prominently displayed on the device and package label and be represented in both human readable and bar code format, in accordance with the FDA Final Rule.

There may be a time when both the GTIN and the HIBCC barcodes appear on the label. Either of these UDI formats are usable.
What is GUDID?
What is GUDID?
The FDA Global Unique Device Identification Database (GUDID) is a publically accessible database that will serve as a reference catalog for every device with an identifier intended for the US market and manufactured after the relevant compliance date. Philips is required to prepare a data set specific to each GTIN (Device Identifier) and upload the data to the GUDID. Find out more information about the AccessGUDID.
Why can't I find some Philips products listed in the GUDID?
Why can't I find some Philips products listed in the GUDID?
The product may not yet need to be UDI compliant. UDI is implemented over 5 years based on its US FDA class. In addition, there is a grace period for submission to public availability of the records by the FDA Global UDI Database (GUDID).
What if my organization isn't doing anything with GS1?
What if my organization isn't doing anything with GS1?
We will continue to use the catalog numbers so you can order as you have been ordering. Nothing will change except that you will see GS1 barcodes on the packaging and products.

Ordering and support

Will product numbers change with UDI labeling?
Will product numbers change with UDI labeling?
No. Philips will continue to display model number (REF) and/or catalog numbers on product labels.
Can products be ordered using GTINs?
Can products be ordered using GTINs?
Not currently. Continue to use your current method to order Philips products.
When I call for service or support, what part(s) of the UDI should I reference?
When I call for service or support, what part(s) of the UDI should I reference?
Reference the same information as always; none of our policies or procedures are changing at this time.
Will the invoice and packing slip change?
Will the invoice and packing slip change?
The invoice and packing slip will remain the same. We are looking to add the UDI in the future.

GDSN and Data pools

More information and resources

Where can I find a list of Philips GTINs?
Where can I find a list of Philips GTINs?
You can download a list of Philips products from AccessGUDID.
Who can I contact for more information on Philips UDI Initiative?
Who can I contact for more information on Philips UDI Initiative?

Philips Contact Information:

Email: UDI@Philips.com

Website: https://www.philips.com/UDI

Health Systems: https://www.usa.philips.com/healthcare/about/contact

Personal Health Product contacts : https://www.philips.com/c-cs/support-country-selector.html
Where can I find additional information on UDI?
Where can I find additional information on UDI?
GHX Blog: www.thehealthcarehub.com

FDA Medical Device/UDI website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

GS1 website: www.GS1US.org/Healthcare

AccessGUDID: https://accessgudid.nlm.nih.gov/source=govdelivery&utm_medium=email&utm_source=govdelivery

IMDRF: http://www.imdrf.org

GDSM: http://www.gs1.org/gdsn

UDI Frequently Asked Questions

Understanding the UDI initiative

UDI Unique Device Identification

GS1 Standards Product Identification

DI Device Identifier (DI)

GTIN Global Trade Item Number (01)

PI Production Identifier (PI)

AI Application Identifier (AI)

DI + PI = UDI

GTIN or GTIN + AI(s) = UDI

Final Rule

Sept 24, 2014

Sept 24, 2015

Sept 24, 2016

Sept 24, 2018

Labels and packages must contain UDI Dates must be formatted by YYYY-MM-DD Products must be submitted to FDA UDI Database

Final rule Published Sept. 24, 2013

Class III

Implantable or Life Sustaining/ Supporting

Class II

Class I

Labeling and barcoding

Final Rule

Sept 24, 2014

Sept 24, 2015

Sept 24, 2016

Sept 24, 2018

Labels and packages must contain UDI Dates must be formatted by YYYY-MM-DD Products must be submitted to FDA UDI Database

Final rule Published Sept. 24, 2013

Class III

Implantable or Life Sustaining/ Supporting

Class II

Class I

GS1, GDSN, GLN, GTIN, GMDN & GUDID

Ordering and support

GDSN and Data pools

More information and resources

UDI
Unique Device Identification

GS1 Standards
Product Identification

DI
Device Identifier (DI)

GTIN
Global Trade Item Number (01)

PI
Production Identifier (PI)

AI
Application Identifier (AI)

Sept 24,
2014

Sept 24,
2015

Sept 24,
2016

Sept 24,
2018

Labels and packages
must contain UDI

Dates must be formatted by YYYY-MM-DD

Products must be submitted to FDA UDI Database

Final rule Published
Sept. 24, 2013

Implantable
or Life
Sustaining/
Supporting

Sept 24,
2014

Sept 24,
2015

Sept 24,
2016

Sept 24,
2018

Labels and packages
must contain UDI

Dates must be formatted by YYYY-MM-DD

Products must be submitted to FDA UDI Database

Final rule Published
Sept. 24, 2013

Implantable
or Life
Sustaining/
Supporting