Download GUDID Schema

Coming Soon: GMDN Enhancements

NLM will update AccessGUDID to include more Global Medical Device Nomenclature (GMDN) information - Term Codes, Code Status (Active or Obsolete), and a GMDN Implantable flag (True or False). Device records containing a GMDN Preferred Term (gmdnPTName) will include the equivalent GMDN Term Code on AccessGUDID.The following are the new GMDN fields:

• GMDN Term Code
• GMDN Implantable
• GMDN Code Status

The Schema files are updated with the new GMDN terms. Please take a moment to review the information and ensure your system is able to download and process the updated files.

New Data Elements

New on April 2, 2018: updates to AccessGUDID data! The following new data elements are now available on AccessGUDID, in the download files, and in the APIs. More easily track GUDID device record updates, manage changes, and link to other data sets.

• Public Version Number
• Public Version Date
• Public Version Status (new/update/delete)
• Public Device Record Key
• Labeler D-U-N-S® Number
• FDA Premarket Submission Number*
• FDA Premarket Supplement Number*

The updated schema file, sample download records and read-me-first files are included in the zip file below. Please take a moment to review the information and ensure your system is able to download and process the updated files.

* As of July 9, 2018, values for FDA Premarket Submission Number and FDA Premarket Supplement Number are included in the device record when available and publicly releasable.

Device record versioning is new

Starting April 2, 2018, you can track changes to device records using the new data elements Public Version Number, Public Version Date, Public Version Status, and Public Device Record Key.

Public Device Record Key is the primary key for device records on AccessGUDID: it can be used to uniquely identify a device record and maintain its history. Public Device Record Key will never change for an individual device record even if the device record’s Primary Device Identifier (DI) Number changes.

The table below shows the information you can expect to see in the new data elements Public Version Number, Public Version Date, and Public Version Status.

Action	Public Version Number	Public Version Date	Public Version Status	Device Record Status	Additional Information
Record released to AccessGUDID for the first time	1	Date the record is initially released to AccessGUDID	New	Published
Record update released to AccessGUDID	Add 1 to previous Public Version Number	Date the updated record is released to AccessGUDID	Update	Published
Record is removed from AccessGUDID	Add 1 to previous Public Version Number	Date the record removal notification is sent to AccessGUDID	Delete	Unpublished/Deactivated	Record will no longer be searchable via AccessGUDID Search interface or APIs
New data elements added to existing records on AccessGUDID on April 2, 2018	2	April 2, 2018	Update	Published	Public Version Number 1 of the existing records is implied prior to April 2, 2018

Current Schema File

The GUDID schema file is a ZIP file containing XSD files. The XSD files explain the format for GUDID release XML files. The GUDID schema ZIP file also contains an Excel file with version history for the XSD files.

• GUDID_Download_Schema_20230616.zip
  • Date Created: Aug 14, 2023
  • Number of Files: 4
  • File Size: 22.1 KB
  • MD5 Checksum: b1a0d5276deadba2fa2a4025d8b5c43e