DI Record

March 10, 2016

Indira R Konduri

GUDID Program Manager

Informatics Staff

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Learning Objectives 

• Obtain an overview of GUDID

• Understand the DI record and the data elements

• Understand how to manage your DI record so the 

information is current

• Learn about best practices for better GUDID data
UDI = DI + PI

Device Identifier(DI) = mandatory, fixed portion of a UDI that identifies the 

specific version or model of a device and the labeler of that device

Production Identifier(PI) = a conditional, variable portion of a UDI that 

identifies one or more of the following when included in the UDI:

Lot or batch number, Serial number, Expiration date, Manufacturing date, 

and, for an HCT/P regulated as a device, the distinct identification code

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Repository of key device identification information

Contains ONLY the DI; PIs are not submitted to nor stored in 

the GUDID

Contains only PI flags to indicate which PIs are on the device 

UDI
GUDID Overview

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accessgudid.nlm.nih.gov 
GUDID Web Interface

• Secure Web Application

• Submission of device information one 

record at a time by Labelers

• Suitable for those with small submission 

volumes

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DI Record and Data Elements 

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• A Device Identifier(DI) identifies – 

– A given version or model of a device AND

– The Labeler of the device

• DI Record in GUDID

– Device Identifier + GUDID Data Element values

Device Identifier Record

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The majority of the DI record information is on the device label
GUDID DI Record 

• Web Interface – created by LDE users

• HL7 SPL Submission option – submitted as xml files

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Primary DI = DI on the base package. Base Package is the lowest 

package level containing a full UDI
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US Test Company 911

899 Eaton Ave

Bethlehem, PA

The company name and address associated to the Labeler DUNS 

Number should match the company name and address on the device 

label. A Doing Business As (DBA) name is also acceptable

Labeler DUNS Number
Labeler DUNS and the GUDID DI Record

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DI record Company Name and Address is associated to the Labeler DUNS Number 
Labeler DUNS and the AccessGUDID DI Record 

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DI record Company Name associated to the Labeler DUNS Number
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Levels of Packaging

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Packages in GUDID

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Primary DI = base package DI

Higher level Package DIs for a given version or model are entered as 

part of the same DI record.

Please DO NOT enter separate DI records for higher level packages 
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Global Medical Device Nomenclature
GMDN 

• GMDN = Global Medical Device Nomenclature

• Provides a way to group or categorize devices

• Consists of:

– GMDN Code

– GMDN Preferred Term

– GMDN Preferred Term Definition

• Required element in GUDID

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DI Record Management

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DI Record Life Cycle

• Managing entry and edits to device identification 

information throughout the life of the device

• 3 DI record states – 

– Draft 

– Unpublished

– Published

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• Use to “test/learn” GUDID

• Saved in the system, but not “submitted”

• Unlimited editing 

• Purged after 180 days of inactivity 

• Allows for Review prior to submitting

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Review checks 

record against 

business rules

Draft DI Record
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Cannot Submit a record with errors

Fix errors and click Review or re-Save Draft

Draft DI Record- Review Failed
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Review Passed! May submit record! 

Submit Or re-Save Draft

Draft DI Record- Review Passed
Submitted DI Record

• No longer in DRAFT state – time to pay attention 

to GUDID business rules!

• Publish Date determines DI record state --

Unpublished OR Published

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DI Record Publish Date

• Determines when a DI record is saved in the “published” 

state 

• GUDID requires Publish Date to be today or in the future.

• GUDID submission requirements are met the date the DI 

record is saved in the “published” state

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Moving between DI Record States

Draft

Unpublished Published 

Business rules pass

Publish Date in future 

Business rules pass

Publish Date is today

Nightly automated check

If Publish Date = today

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• DI record has passed review

• DI record was submitted 

• Publish Date in the future

• Unlimited editing

• Records are NOT released to AccessGUDID

• Can be copied to create new DI records

Unpublished DI Record
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Unpublished DI Record is a Submitted DI record with a future Publish Date

Record will move to “Published” state on the set Publish Date

Unpublished DI Record
Moving between DI Record States

Draft

Unpublished Published 

Business rules pass

Publish Date in future 

Business rules pass

Publish Date is today

Nightly automated check

If Publish Date is today

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• DI record has passed review 

• DI record was submitted 

• Publish Date is today OR in the past

• Limited editing

• Records are released to AccessGUDID

• Can be copied to create new DI records

• GUDID submission requirements are met the date the 

DI record is saved in the “published” state

Published DI Record
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DI Record Publish Date in the past

Published DI Record
DI Record Life Cycle

• DI Record Life Cycle = DI record states + business rules

• DI record state determines applicable business rule

Draft DI Record

• Business rules N/A

• Publish Date N/A

• Unlimited Editing

• Not released to 

AccessGUDID

• Not available via HL7 SPL

Unpublished 

DI Record

• Business rules passed

• Publish Date in future

• Unlimited Editing

• May be copied

• Not released to 

AccessGUDID

Published 

DI Record

• Business rules passed

• Publish Date is today or in 

future

• Limited Editing

• May be copied

• Released to AccessGUDID

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DI Record Life Cycle

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DI Record Management 

Editing Published DI records

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New DI Trigger Element – when changed, 

requires a new DI and new DI record in GUDID. 

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• Unlimited Editing, 

except for Publish 

Date

• Please review your 

data in GUDID!

During Grace 

Period 

• Record released to 

AccessGUDID

• New DI Trigger Data 

Elements – no edits

• Limited Editing

After Grace 

Period

Grace Period = 30 calendar days*

Grace Period Applies to Published DI Records

*Grace period subject to change

Publish Date Grace Period Start Date Grace Period End Date

Friday, January 15, 2016 Saturday, January 16, 2016 Monday, February 15, 2016

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GUDID and Data Quality

• Start with GOOD Data

• Review your data in GUDID During-the-Grace-Period

– Export your records from GUDID and review/validate

• Do not wait to do your review after records show up on 

AccessGUDID, which is AFTER the grace period when 

editing is limited

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Best Practices for Better Data

Data Element Data Quality Issue

Device Identifier Ensure your DI is correct – validate your check digits

Version or Model Do not include the word “Model” or “Version”

If no Version or Model available, enter Catalog Number

Device Description Do not leave blank; recommend approved/cleared indications 

for use

Clinically Relevant Size Do not include size under ‘Device Description’ or ‘Brand Name’

Use List of Values vs. “Device Size Text, Specify”

GMDN Code One code sufficient for most medical devices

Donation Identification 

Number (DIN)

Applicable to ICCBBA Device Identifiers ONLY

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Steps for Success!

1) Review resources on the UDI Website

2) Select Issuing Agency and label your devices with UDI

3) Determine primary submission option

4) Gather your data

5) Understand the GUDID Account Structure

6) Identify/Obtain DUNS numbers

7) Obtain a GUDID Account

8) Submit DI records

9) Subscribe to get notified about GUDID System Status

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GUDID System Status

• Subscribe to GUDID Email Alerts by visiting our 

website

• Scheduled downtimes -- email alerts sent and posted 

on www.fda.gov/udi

• Unscheduled downtimes

– Visit www.fda.gov/udi for information

– If no information, report issue via FDA UDI Help Desk 

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• It is time to get started! 

• Utilize the resources available on our website

• Do not forget data quality

• Be sure to understand the DI record edit rules 

• Use the grace period effectively to ensure your device 

information is accurate

• Subscribe to the GUDID System Status notification

Your Call to Action

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 80 modules - videos, audio recordings, power point presentations, software-based 

“how to” modules

 accessible on your portable devices: http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE)

 If you have a question - Email: DICE@fda.hhs.gov 

 Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am – 12:30 pm; 1-4:30 pm EST)

 Web Homepage: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs-- DivisionofIndustryandConsumerEducation/default.htm 

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