Device SubStatus
Die "Device SubStatus" Angaben werden je UDI-DI verwaltet. Das Programm ist über das Programm Artikel / Teile (US17000) aufrufbar.
Weitere Informationen sind unter Stammdaten UDI beschrieben.
Verwendung dieses Programms
- US17000 Artikel
Felder
Device SubStatus
| Feldbezeichnung | Erklärung |
|---|---|
| Device SubStatus | SubStatus of the Device (Recalled, Field safety corrective action initiated). |
| Recall Precision | When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are required (description of the serialnumber / lot number, etc.). Field stores the details of the recalled elements (batch numbers, lots numbers , etc.) of the Device - when the Scope of Recalled is entered manually by the user (not by referencing an FSN). |
| Scope of Recall | When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are required (description of the serialnumber / lot number, etc.). Field defines how the Scope of the Recall is defined (by Lot number, Serial Number , etc.). |
| Start date Substatus | Start Date when the Substatus has been initialised. |
| End date Substatus | End Date when the Substatus has been closed. |
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. |