AccessGUDID

The FDA's Global Unique Device Identification Database (AccessGUDID) is a comprehensive catalog of medical devices distributed in the United States. It encompasses critical identification, regulatory, and clinical information for millions of devices, providing a standardized way to track and trace medical equipment. The AccessGUDID is crucial for enhancing patient safety, improving medical device tracking, and streamlining healthcare supply chains. Here's a commercial overview of the FDA AccessGUDID dataset:

**Origin and Purpose:**

- **Standardized Device Tracking:** The GUDID dataset was established by the FDA to serve as a central repository for Unique Device Identifiers (UDIs), ensuring every medical device can be accurately and globally identified throughout its lifecycle.
- **Patient Safety and Recall Management:** It serves as a vital tool for healthcare providers, manufacturers, and researchers to quickly identify devices during recalls, track adverse events, and facilitate clinical evaluations.

**Key Components of the Dataset:**

- **Device Identification:** Includes Primary DI (Device Identifier), brand name, version or model numbers, and detailed device descriptions.
- **Regulatory Information:** Data on FDA product codes, premarket submission numbers (such as 510k and PMA), and global medical device nomenclature (GMDN) codes.
- **Clinical and Safety Parameters:** Information regarding sterility requirements, single-use status, prescription (Rx) versus over-the-counter (OTC) designations, latex content, and MRI safety status.
- **Manufacturer Details:** Labeler and company names, corporate contact information, and global location numbers (GLN).

**How YOU can leverage this dataset:**

- **Healthcare Analytics and Operations:** Essential for hospitals, clinics, and software vendors to integrate standardized device data directly into Electronic Health Records (EHR) and internal inventory management systems.
- **Supply Chain Optimization:** Provides a rich data source for distributors, group purchasing organizations (GPOs), and manufacturers to track product flow, manage inventory lifecycles, and reduce procurement errors.
- **Recall and Safety Management:** Informs rapid response strategies for medical device recalls, assisting risk management teams in identifying affected products and improving overall patient safety.
- **Market and Regulatory Research:** Assists medical device companies, investors, and industry analysts in assessing market landscapes, regulatory classifications, and competitor portfolios.

原始信息汇总

AccessGUDID 数据集概述

数据集基本信息

• 数据集名称: AccessGUDID
• 提供商: Element Data
• 获取方式: 免费试用
• 试用期限: 7天
• 数据刷新频率: 月度
• 地理覆盖范围: 美国（所有州）
• 类别: 健康与生命科学、真实世界数据 (RWD)

数据集描述

该数据集是美国食品药品监督管理局（FDA）的全球唯一器械识别数据库（GUDID）。它是一个包含在美国分销的医疗器械的综合目录，涵盖数百万设备的识别、监管和临床信息，为医疗器械的跟踪和追溯提供了标准化方法。

数据内容与关键组成部分

设备识别信息

• 主要器械标识符 (Primary DI)
• 品牌名称
• 版本或型号
• 详细的设备描述

监管信息

• FDA 产品代码
• 上市前提交编号（如 510k 和 PMA）
• 全球医疗器械术语 (GMDN) 代码

临床与安全参数

• 无菌要求
• 单次使用状态
• 处方药 (Rx) 与非处方药 (OTC) 标识
• 乳胶含量
• MRI 安全状态

制造商详情

• 标签商和公司名称
• 企业联系信息
• 全球位置码 (GLN)

数据字典与结构

数据集包含以下主要对象（部分）：

• V_DEVICE
• V_IDENTIFIERS
• V_ENVIRONMENTALCONDITIONS (示例查询中提及)

数据预览列表示例（部分字段）：

• PRIMARYDI (Varchar)
• PUBLICDEVICERECORDKEY (Varchar)
• BRANDNAME (Varchar)
• VERSIONMODELNUMBER (Varchar)
• COMPANYNAME (Varchar)
• DEVICEDESCRIPTION (Varchar)
• SINGLEUSE (Boolean)
• MRISAFETYSTATUS (Varchar)
• RX (Boolean)
• OTC (Boolean)
• DEVICESTERILE (Boolean)

应用场景

医疗保健分析与运营

医院、诊所和软件供应商可将标准化设备数据直接集成到电子健康记录 (EHR) 和内部库存管理系统中。

供应链优化

为分销商、集团采购组织 (GPO) 和制造商提供丰富的数据源，以跟踪产品流、管理库存生命周期并减少采购错误。

召回与安全管理

为医疗器械召回提供快速响应策略，协助风险管理团队识别受影响产品并提高整体患者安全。

市场与监管研究

协助医疗器械公司、投资者和行业分析师评估市场格局、监管分类和竞争对手组合。

使用示例

查询示例：统计“储存环境温度”要求低于 40 摄氏度的设备数量。 sql select count(*) from "V_ENVIRONMENTALCONDITIONS" B where B.STORAGEHANDLINGTYPE = Storage Environment Temperature and B.STORAGEHANDLINGHIGH_VALUE < 40

支持信息

• 销售联系: [e-mail]
• 支持联系: [e-mail]
• 云区域可用性: 支持 AWS 多个区域（如亚太地区雅加达、孟买、大阪、首尔等）
• 法律条款: 标准条款