Clinical Investigation
Hier können die UDI-DI spezifischen Informationen zu "Clinical Investigation" hinterlegt werden.
Weitere Informationen sind unter Stammdaten UDI beschrieben.
Verwendung dieses Programms
- US17000 Artikel
Felder
Überschriftsformat
| Feldbezeichnung | Erklärung |
|---|---|
| Basic UDI-DI | Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.). The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together. |
| Primary DI Number | The Primary Device Identifier (DI) is the DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements. If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent. The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. |
Clinical Investigation
| Feldbezeichnung | Erklärung |
|---|---|
| Clinical Investigation ID | Clinical Investigations associated to the Basic UDI or UDI-DI. References the Clinical Investigation Link, storing the details of Clinical Investigations associated to the Basic UDI-DI or UDI-DI. |
| Country (non EU) | Countries outside EU were Clinical Investigation is performed. List of Countries were the Clinical Investigation has been performed. Field is optional and can be provided only for Clinical Investigations performed Outside EU (Non EU Countries only). If provided, the Clinical Investigation is considered to be NonEU Clinical Investigation. |