The GUDID DI Record with Indira Konduri 

Slide 1

Hello, my name is Indira Konduri and I am the Program Manager for the Global 

Unique Device Identification Database, the GUDID. Today's presentation will 

focus on The GUDID DI Record. 

Slide 2

In today's presentation, I'll start with an overview of the GUDID, which we call the 

GOOD-ID for short. Next, we'll delve into the device identifier record, the DI record 

--- so you understand what the DI record is, and learn about the data elements in 

a DI record. Then I'll talk about how to manage your DI record through the life of 

your device so your information stays updated. And I'll also cover best practices 

for better GUDID data

Slide 3

Let's review some basics. UDI, the Unique Device Identifier, is composed of two 

parts. The Device Identifier or DI, highlighted in yellow on the slide, and the 

Production Identifier or PI, shown in green on the slide. The Device Identifier is 

the fixed portion of the UDI and identifies a given version or model of a device 

AND the labeler of that device. The Production Identifier is the variable portion of 

the UDI. It identifies the Lot or batch number, Serial number, Expiration date, 

Manufacturing date, and, for Human Cellular and Tissue based products 

regulated as devices, the distinct identification code, when included in the UDI.

Slide 4

The GUDID is the repository of key device identification information. GUDID only 

contains the DI. We do not collect the actual PIs, such as the lot or batch number 

in GUDID. What we do collect are PI flags, which are Yes or No answers that 

indicate which PIs are in the UDI.

Slide 5

Here's a high level view of GUDID. On the right hand side is AccessGUDID. Data 

that labelers submit to GUDID is made available to patients, health care providers 

and any member of the public through AccessGUDID.

The top blue box shows the two ways labelers can submit information to GUDID -

the GUDID HL7 SPL Submission option and the GUDID Web Interface option. The 

GUDID HL7 SPL submission option allows labelers to send their information as 

XML files via the FDA Electronic Submissions Gateway. You will hear more about 

this in the session following this.
Slide 6

The GUDID Web Interface submission option is a secure web application. 

Labelers can enter device information one record at a time using manual data 

entry. The web interface is suitable for labelers with small volume of 

submissions.

Slide 7

Let's move to the GUDID DI Record and Data Elements

Slide 8

Again, the DI is the fixed part of the UDI. It identifies a given version or model of a 

device AND the Labeler of that device. A DI Record in GUDID is the Device 

Identifier + GUDID Data Element values. 

Slide 9

Here you see a physical label of a fictitious device. Most of the values for the DI 

record data elements come directly from the device label. For example, on the top 

left you see Brand Name. In the middle you see the UDI, which has the DI and PI. 

Further down, you can find storage and handling, a single use designation and 

the labeler name and address. 

Slide 10

Getting into the GUDID DI record itself, remember there are two ways labelers 

can submit DI record information - Web Interface and the HL7 SPL. Now, if you're 

using the Web Interface, the Labeler Data Entry (LDE) user will be entering the 

records. Those using the HL7 SPL submission option will submit them as xml 

files.

Over the next few slides I'm going to walk through the GUDID Data Elements. The 

screen shots will be from the GUDID Web Interface application. But the 

information about these data elements applies to both submission options.

To start out, we have 3 groups of GUDID data elements - Device Information, 

Device Status and Device Characteristics. Let us take a look at each grouping. 

Slide 11 

Device Information. These data elements cover basic device identification 

information. From the top and moving left to right, Issuing Agency. Choose from 

one of the FDA-accredited Issuing Agencies. For this DI record it is HIBCC.

Primary DI Number - this is the DI on the base package, the lowest level of a 

medical device package containing a full UDI. 

Device Count is the number of medical devices in the base package. 
Unit of Use is an unmarked DI and is applicable when the device count is greater 

than 1.

I'm skipping Labeler DUNS Number, Company Name and Address for now. We'll 

come back to it later.

Brand Name, Version or Model, Catalog Number and Device Description should 

be self-explanatory. Let us skip DI Record Publish Date for now, we will come 

back to it later.

On to Commercial Distribution End Date; this is the date after which the device is 

no longer offered for sale by the labeler on record. Commercial Distribution 

Status is automatically updated by the system. When an End Date has been 

entered, the status will change to show "No Longer in Commercial Distribution" 

after that date.

Let's now talk about Labeler DUNS Number. In GUDID, the DUNS number is used 

to pull Company name and Address from the DUNS database. It's important to 

make sure that the company name associated to the Labeler DUNS number 

matches the company name on the physical label of the device. On this fictitious 

label, the company name and address are circled in red. The DI record in GUDID 

should reflect the same company name as the one on the label. The company 

address in GUDID should also match what's on the label, if possible. 

We know that some of you use the DUNS Doing Business As or the DBA name. 

You may use the DBA name associated to your Labeler DUNS in GUDID if that is 

what's shown on the label.

Slide 13

Here's how the Company Name and Address associated to your Labeler DUNS 

looks in a GUDID DI record. 

Slide 14

Here's why this is important. AccessGUDID is the portal where we make GUDID 

information publicly available. If someone has a device label in hand, and 

searches for the device record using the company name on the label, the record 

that's retrieved should show the same company name as the one on the label.

Slide 15 

Let's go back to the Data Elements, and continue on with the Device Information 

group of elements. Next come Alternative and Additional Identifiers for a device. 

Direct Mark DI is a DI marked directly on the device itself. You only need to 

provide this in GUDID if the direct mark DI is different from Primary DI. If your 

device has a DI issued by an Issuing Agency that is different from the Primary DI 

Issuing Agency, you would enter it under Secondary DI. Package DI - These are 

DIs assigned to higher level packages. More on packages in just a minute. 
So as you see, all Device Identifiers for a for a given version or model are part of 

the same DI record. Customer Contact information is in the bottom - phone and 

email information that customers can use to contact you if they need more 

information on a device.

Slide 16

Now let’s talk a little more about packages. A device package contains a fixed 

quantity of a particular version or a model of a device. Each level of package 

requires a different DI.

On the left side of the slide, we have a catheter in a base package with DI 1001. 

Going across the top, 30 catheters with DI 1001 are put into a box. The box is the 

second level of package; it is assigned a Package DI of 2001. Moving right from 

package 2001, 12 boxes with package DI 2001 are put into a larger box. The 

larger box is the next level of package with Package DI 3001. At the bottom is 

another package level. In this case, 50 catheters with DI 1001 are put into a box, 

and gets a Package DI of 2002.

Slide 17

Here's how this package configuration would be entered in GUDID. On the top 

you see that Base package DI 1001 is the Primary DI. In the bottom you see the 

higher level packages are all entered as part of the same DI record. So from our 

example, package DI 2001, 2002, and 3001 are all part of the same DI record. 

Slide 18

Let's move to the second grouping of data elements and that is Device Status. 

This group of elements primarily captures regulatory type information. On the 

top you see check boxes to indicate if the device is a Human Cellular or tissue 

based product, a Kit or a Combination Product. Next, you provide Premarket 

Submission, FDA Product Code, and FDA Listing Number. The GMDN code is 

circled in red. GMDN stands for Global Medical Device Nomenclature.

Slide 19

GMDN is an international nomenclature used to group devices into broad, high 

level categories. It consists of GMDN Code, Preferred Term Name and Preferred 

Term Definition. GMDN codes are created and maintained by the GMDN Agency. 

You need to be a member of the GMDN Agency to obtain GMDN codes. 

The FDA has developed FDA Preferred Term codes, to allow companies to select 

a GMDN Preferred term, but it is preferable for companies to obtain a code from 

the GMDN agency. The FDA Preferred Term codes are available when labelers 

login to GUDID. If your device requires a new GMDN code it may take time to 

obtain one, so please make sure you allocate enough time to identify and obtain 

GMDN codes for your devices.
Slide 20

Now to the third grouping of data elements, Device Characteristics. Going clock 

wise from top right, you see For Single Use, Latex, MRI information, and 

Prescription Status. Finally, you see the PI flags mentioned earlier. The PI or 

Production Identifier may contain the lot or batch, serial number, expiration, 

manufacturing date, and Donation Identification Number. In GUDID, the actual Lot 

or Batch or the Serial Number isn't captured. Instead, you enter YES or NO to 

indicate which PIs are in the UDI.

Slide 21

And finally you see Size, Storage and Handling, and Sterility information. That 

completes the data elements in a DI record. While I've shown you screen shots 

from the GUDID Web application, remember that these data elements are 

applicable to both submission options: the GUDID Web Interface where you 

manually type in your device record and the GUDID HL7 SPL Submission option 

where information is sent as XML files. 

Slide 22

Now that we've covered what a DI record is, let's understand how to manage your 

DI record.

Slide 23

The GUDID DI record life cycle helps you manage the entry and edits of 

information in your DI record throughout the life of the device. There are 3 DI 

record states in GUDID: Draft, Unpublished and Published.

Slide 24

Starting with the Draft DI record state. A draft DI record is simply that, a draft. If 

you are a GUDID web interface user, creating draft DI records is a way to test or 

learn about GUDID and DI records. The Draft DI is entered and "saved" into the 

system. It is not "submitted" to the system. Stay with me, I will explain what 

submitted means in a minute. You may edit a draft DI record as much as you like. 

Draft DI records with no activity will be deleted from GUDID after 180 days.

Once you enter a GUDID Draft DI record, you can click the "Review" button as 

shown circled in red to your right, to see if your DI record passes all the GUDID 

business rules. If the record doesn't pass business rules, you CANNOT submit. 

What do I mean by that?

Slide 25

Here you see when Review you click review, the system says there are errors. 

You cannot "submit" a record with errors, there is no Submit button for you to 

click. You can now resave as a draft. Or, fix the error and click "Review" again to 

see if you passed this time. Or you may cancel.
Slide 26

Let's say I've fixed the error and clicked review. Now the DI record passed 

because the record was entered correctly! So SUBMIT is available as one of blue 

buttons on the right side. At this point, you can resave as a draft, submit the 

record, re-edit the record or cancel and exit.

Slide 27

Once your record is "submitted", it is no longer in the draft state. You now have 

"Submitted" the record by passing all the business rules. After the record leaves 

the draft state, the DI record Publish Date determines whether the record is in the 

Unpublished or Published state. 

Slide 28

DI record Publish Date is a critical concept. The Publish Date determines when a 

DI record is saved in the "published" state. The system requires the Publish Date 

to be today or in the future. Your GUDID submission requirements are met the 

date the DI record is saved in the "published" state.

Slide 29

Let's use this picture to depict the relationship between the 3 record states. 

Starting from the top, you start with a Draft DI record. Walking down the left 

arrow, you click the "Review" button, and pass all the business rules. The Publish 

Date is in the future, so the record will be in the Unpublished State. Walking 

down the right arrow, you click the "Review" button, and pass all the business 

rules. The Publish Date is today, so the record is in the Published State.

Slide 30

So let's get into the Unpublished DI record a little more. As you just saw, an 

Unpublished DI record is a DI record that has passed "Review", meaning it has 

passed all the business rules AND has been submitted to GUDID by clicking the 

Submit button AND has a future publish date. 

Unpublished records can be edited an unlimited number of times. These records 

are not released to AccessGUDID, because they are "not published", yet. Now 

here's a key feature: any record that has passed business rules can be "copied". 

That means an unpublished DI record can be copied to create new DI records. 

This can help reduce data entry burden if you're using the manual data entry 

option because if you copy records that are very similar, the only changes you 

need to make would be to update information that would be specific to a given 

version or model --- for example, the primary DI of the record would have to 

change for a different version or model.

Slide 31

Let's take a look at an unpublished DI record. On the top right hand side you see 

the buttons for Copy, Edit, and Cancel. At the bottom you see the DI record 

Publish date set to a future date.
Slide 32

Let's talk about what happens when a record goes from Unpublished to 

Published, in other words, moving across the bottom of the slide. Unpublished 

records have a future publish date. Every day, after mid-night, the GUDID system 

checks to see if there are Unpublished DI records with Publish Date = today. If 

there are, then the system changes the record to Published status automatically. 

So if you have a record with Publish Date tomorrow, then tonight after midnight, 

the automated check would change the status of your record from Unpublished 

to Published.

Slide 33

Now let us understand the Published DI Record state. A DI record that has passed 

"Review", meaning it has passed all the business rules AND has been submitted 

to GUDID by clicking the Submit button AND has a publish date of today or in the 

past, is a Published DI record

Editing is limited on published records. These records are released to the public 

on AccessGUDID. The records on AccessGUDID must be accurate and 

dependable, so they can't be changing constantly. This is one of the reasons for 

limited editing. Since a Published record has passed business rules, it may be 

"copied" to create new DI records. And to emphasize from earlier, your GUDID 

submission requirements are met the date the DI record is saved in the 

"published" state.

Slide 34

Here's how a published DI record appears in the database. At the top right, you 

see the buttons for Copy and Edit. At the bottom left, you see the DI record 

Publish date set to a date in the past.

Slide 35

These next two slides provide high level summaries of the DI record life cycle and 

the points we have covered for the Draft, Unpublished and Published states. The 

DI record state determines the applicable business rule. This slide can be used as 

a quick reference tool.

Slide 36

This second summary slide is for those of you who like flow charts. You can use 

it to follow the path of your DI record through its life cycle. You can also find this 

flow chart in the GUDID Guidance Document. Please take a look at your leisure. 

Slide 37

I've talked about how draft and unpublished records have unlimited editing, but 

some edits are restricted for Published records. Let's look at editing Published DI 

records a little closely.
Slide 38

I want to introduce another concept to you, the New DI Trigger Data Element. If 

you change a GUDID data element that is designated as a New DI Trigger, you 

won't be able to simply edit a Published DI record to change that element once 

edit restrictions go into effect. Instead, you will need to assign a new DI to your 

device and submit a new DI record to GUDID. 

Here is a page from the GUDID Data Elements Reference Table. The table lists all 

the GUDID Data elements, along with other features for each element. The last 

column indicates whether a data element is a new DI trigger. The top data element 

is "For Single Use". It's a new DI trigger, so the column says YES. That's 

because a device that's intended for single use is not the same as a device that 

can be used multiple times. Since it is no longer the same device, if you have to 

change this data element, AND your DI record is in the published AND has edit 

restrictions, you need to assign a new DI and enter a new DI record in GUDID. 

Similarly, "Device Packaged as Sterile" is a new DI trigger. If the device was 

originally packaged and used as sterile, but is then provided non-sterile, it's not 

the same device and can't be identified by the original DI. To change this data 

element value once your device record is in the Published state with edit 

restrictions, you would need to provide a new DI and a new GUDID record.

Slide 39

What if you make a mistake on one of the new DI trigger data element and did not 

catch it until after the record is published? 

The Grace Period exists for just this type of a situation. The grace period is 

currently 30 calendar days. If you have a record with Publish Date of January 15, 

2016, the Grace Period starts the day after, which would be January 16, 2016 and 

ends on February 15, 2016. 

During the Grace Period, the only data element you cannot edit is the DI record 

Publish Date. Other than that, unlimited editing still applies to your records. So if 

you did make an error, even on a data element that is a new DI trigger, you may 

edit that record. 

After the end of the 30-day Grace Period, the record is released to AccessGUDID, 

for any member of the public to see and use. Other data elements also have 

certain limits on editing. So the bottom line is: PLEASE use the grace period! 

Take the time to review your records, make any edits or corrections before the 

record is available for public view.

Slide 40

And that leads us to GUDID Data Quality. GUDID serves as a master repository 

for device identification information. We think of it as the gold standard for device 

identification!
So start with good data! Bake in data quality into all your processes as you 

prepare for GUDID. Do everything you can to ensure that your records are 

accurate when they are submitted, and be sure to make full use of the grace 

period. GUDID has an "export" feature that can be used to export all the DI 

records you have entered into GUDID. This is a great tool to use to review and 

validate against your source system data. If you find problems, be sure to correct 

those records as necessary during the grace period.

Finally, please don't wait to review your information until after your records are 

publicly available on AccessGUDID, because by then, the grace period has 

passed and your records have limited editing.

Slide 41

This slide provides best practices for better data. Device Identifier - ensure your 

DI is built correctly, and validate DI check digits. Version or Model - do not 

include the word "version" or "model" - if you have version 2, just put "2" in the 

field. If no version or model number is available, you may enter catalog number. 

Device Description - please do not leave this field blank. We recommend you 

base your description on the approved or cleared indications for use. Clinically 

Relevant Size - Use this field to enter the device size; don't put size in device 

description or brand name, and please use the List of Values when they apply to 

the size of your device. If you need a new size value, send us a request through 

the UDI help desk. GMDN Code - one code is sufficient for most medical devices. 

Remember it is a way to categorize devices into broad groupings, it is not very 

granular. Donation Identification Number is only applicable to devices that use 

the ICCBBA Issuing Agency.

Slide 42

Here are steps that we think will lead to successful GUDID submissions. Start 

with the many resources on our website. They provide greater detail on many of 

the concepts we've touched on today. So take the time to review and use them. 

Select your Issuing Agency and label your devices with UDI. Determine primary 

submission option - GUDID Web Interface or HL7 SPL.

Gather your data, and "bake in" data quality from the beginning. Understand the 

GUDID Account Structure. Identify/Obtain your DUNS numbers. Get a GUDID 

Account. Submit your DI records. And finally, subscribe to get notified about 

GUDID System Status. So how do you do that?

Slide 43

We make every effort to notify users in advance when we have planned GUDID 

system downtimes for enhancements and maintenance. So be sure to subscribe 

to get GUDID System Status email alerts by visiting our website. 

The email alert is also used to notify users of any system related updates such as 

document updates. 
Scheduled downtimes will also be posted on www.fda.gov/udi. Look for GUDID 

System Status web page. If you notice that the system's down during a time it 

wasn't scheduled, first check the GUDID system status on our web page. If there's 

no information, we ask that you report the issue via Help Desk. 

Slide 44

So it is time to get started. You now have the basics. If you need more 

information, please visit our website and take advantage of the resources we 

have available. Do not forget to "bake-in" data quality from the beginning, make 

sure your source system data is correct. Understand the GUDID DI record edit 

rules so you are effective in managing your records throughout the life of the 

device. Use the grace period to review your information and make any edits. 

Subscribe to the GUDID System Status notification so you can be alerted of 

system down-times and any system updates we communicate to our users.

Thank you....

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