Global Unique Device Identification Database GUDID Services

To comply with the GUDID regulations, you must submit information about your devices to the database. These submissions should include the device identifier and any production details. However, if you do not submit your production identifiers, you can still reference them in your GUDID entry (gudid services).

About GUDID FDA USA

The FDA’s Global Unique Device Identification Database is a searchable database that allows anyone to obtain information on medical devices. The medical devices labellers are initially submitting data regarding identification of device, i.e. UDI (Unique Device Identification). 

What Information Needs To Be Sent To The GUDID

The GUDID is a system for labelers and Issuing Agencies to identify and submit device information. A Global Unique Device Identification Database comprises around 50+ data attributes. The system automatically fills in some fields. For example, the Labeler Name and Address field is automatically pulled from the DUNS database, and various Issuing Agencies provide the Device Identifier field. However, some fields, like Device Identifier, must be filled in manually. Fortunately, built-in business rules and a controlled vocabulary help ensure that the data submitted is valid.

Information About Device

The GUDID contains information critical for identifying a device, such as model and version. This information can be submitte manually or through bulk XML file uploads. The information submitted to the GUDID is confidential and not associated with a patient’s identity. A device must submit its GUDID information if it is intended for use in patients. You can find Information about the GUDID on the FDA’s website.

Device Identification Information

The Global Unique Device Identification Database (GUDID), administered by the FDA, is a comprehensive reference catalog of medical devices. It contains information that can help healthcare providers identify individual medical devices. The UDI, or unique device identifier, is print on medical devices and functions as a key to the GUDID. 

The GUDID database contains the information necessary for device identification but does not include information on the patient. UDIs are print in a plain-text format and are barcode scanners easily read it and AIDC technology.

To submit device information to the GUDID, device manufacturers must establish a GUDID account. Each account is tie to a Labeler Organization. Labeler organizations must also have a Dun & Bradstreet DUNS number.

Commercial Distribution

Unique device identification is an essential process in the healthcare industry. That allows consumers and providers to learn more about a specific device’s characteristics. A manufacturer puts a unique identifier on the device’s label. Corresponding to a record in the Global Unique Device Identification Database, which anyone can access. The Center for Devices and Radiological Health at the FDA maintains the database. Device manufacturers load their information into the database and update it as necessary.

To help consumers make informed choices about their health, the FDA is encouraging the industry to use UDIs. The system easily traces devices and other products throughout its distribution networks. UDIs can also help manufacturers identify the products they manufacture and distribute.

 In addition, UDIs can help ensure a more efficient inventory management system and improve the quality of medical services. Furthermore, the database can be link with other information on FDA-approve devices. Help identify substitute devices during shortages. The database will also help detect counterfeit devices.

The Global Unique Device Identification Database (GUDID Services) is a comprehensive reference catalog of medical devices. The database includes information on the device’s manufacturer of medical devices, production, intended use, safety and storage, and handling requirements. It is available to manufacturers, regulators, healthcare providers, insurance companies, and the public.

Numerous Identifiers

The Global Unique Device Identification Database is a central repository for detailed information about medical devices. The database is a critical regulatory requirement for manufacturers of medical devices. It is also known as Good ID and serves as the digital hub for UDI information.

The database contains critical device identification information submitted to the Food and Drug Administration (FDA).