ACCESSGUDID

Medical devices cover a wide range of products - implants, CT scanners, surgical instruments, contact lenses, wheelchairs, and blood glucose tests, to name a few. Unlike drugs, many medical devices currently do not have a unique identifier that clearly distinguishes one product from another. But this is changing. The UDI system will provide a consistent and standard way to identify medical devices throughout their distribution and use by health care providers and patients.

The GUDID contains device identification information submitted by device companies to the FDA. The GUDID contains ONLY the Device Identifier (DI), which serves as the primary key to obtain information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but GUDID data indicates which PIs are on the device label.

The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use.

Please note: The GUDID does not collect or contain any information about patients or anyone who uses a device. The Global Unique Device Identification Database (GUDID - pronounced "Good ID") is a database administered by the FDA as part of the UDI system.

https://accessgudid.nlm.nih.gov/ publishes incremental data on a daily, weekly and monthly basis and full historical data on a monthly basis.

This dataset is a full historical release of devices as at 2022-03-01.

Following pipe "|" delimited text files are published as part of a dataset - primary key for all tables is "PrimaryDI":
1. contacts.txt - Manufacturer contact information for each device identifier.

2. device.txt - Details of the device, such as brand and company name.

3. deviceSizes.txt - Device size information including sizeType and unit of measurement.

4. environmentalConditions.txt - Device storage handling environment information.

5. gmdnTerms.txt - Device product description.

6. identifiers.txt - Information about device issuing agency and device type.

7. premarketSubmissions.txt - Device submission number

8. productCodes.txt - Contains device product code and short description.

9. sterilizationMethodTypes.txt - Contains information about device sterilization requirements.

搜集汇总

背景与挑战

背景概述

该数据集是美国FDA管理的全球唯一医疗器械标识数据库(GUDID)的2022年3月完整历史版本，包含通过DI标识符关联的9类管道分隔文件，涵盖设备基础信息、尺寸规格、存储条件等关键数据，但不涉及任何患者使用信息。数据通过每日/每周/每月增量更新和月度完整发布机制维护。