KVSKBAUDILegacyDeviceExport
Summary: Stores and manages UDI Legacy Device Export records, including Entry No., Released, and Internal Version.
Fields
| Name | Type | Note |
|---|---|---|
| Entry No. | Guid | |
| Released | Boolean | |
| Internal Version | Integer | |
| Active | Boolean | |
| Transferred | Boolean | |
| Description | Text[100] | |
| Issuing Entity Basic UDI-DI | Code[20] | |
| Authorised Representative | Text[15] | |
| Risk Class | Code[20] | |
| Device Model | Text[120] | |
| Device Name | Text[255] | |
| EUDAMED DI | Text[120] | |
| Package DI | Text[120] | |
| Recalled Precisions | Guid | |
| Recall Scope | Option | OptionMembers: None,by Lot number,Serial Number |
| SubStatusStartDate | Date | |
| SubStatusEndDate | Date | |
| Device Status | Option | OptionMembers: None,On the market,No longer placed on the market |
| Device SubStatus | Option | OptionMembers: None,Recalled,Field safety corrective action initiated |
| Unit of Use DI | Text[120] | |
| Secondary UDI - DI | Text[120] | |
| placedOnTheMktCtryId | Text[120] | |
| Direct Marking UDI-DI | Text[120] | |
| PDLink | Text[50] | |
| Basic UDI-DI | Text[120] | |
| Quantity of Device | Integer | |
| Containing latex | Boolean | |
| Maximum number of reuses | Integer | |
| New Device | Boolean | |
| OEMApplicable | Boolean | |
| ReferenceNumber | Text[120] | |
| Reprocessed | Boolean | |
| ReusesApplicable | Boolean | |
| SingleUse | Boolean | |
| Sterile | Boolean | |
| Sterilization | Boolean | |
| Website | Guid | |
| Additional Description | Guid | |
| Trade Name | Guid | |
| UDI-DI | Text[120] | |
| Related Legacy Device | Text[120] | |
| Relationship Type | Option | OptionMembers: None,Legacy-Regulation Device Link |
| MFDeviceIdentification | Text[120] | |
| Issuing Entity UDI-DI | Code[20] | |
| Issuing Entity Unit of Use DI | Code[20] | |
| Issuing Entity Secondary DI | Code[20] | |
| Iss. Entity Direct Marking DI | Code[20] | |
| Issuing Entity EUDAMED DI | Code[20] | |
| Issuing Entity Package DI | Code[20] | |
| Device Status Date | Date | |
| Batch Number | Boolean | |
| Serialization Number | Boolean | |
| Manufacturing Date | Boolean | |
| Expiration Date | Boolean | |
| Software Identification | Boolean | |
| Rel. Legacy Issuing Entity | Code[20] | |
| Quantity of items | Integer | |
| Storage Handling Conditions | Boolean | |
| Critical Warning | Boolean |