KVSKBAUDIUdiDi
Summary: Stores and manages UDI Udi Di 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] | |
| No. of Exports | Integer | FlowField |
| Issuing Entity Basic UDI-DI | Code[20] | FlowField |
| Qty. Packages | Integer | FlowField |
| Recalled Precisions | Guid | |
| Recall Scope | Option | OptionMembers: None,by Lot number,Serial Number,Software Version,UDI-DI |
| SubStatusStartDate | Date | |
| SubStatusEndDate | Date | |
| Device Status | Option | OptionMembers: None,On the market,No longer placed on the market,Not Intended for EU market |
| Device SubStatus | Option | OptionMembers: None,Recalled,Field safety corrective action initiated |
| Unit of Use DI | Text[120] | FlowField |
| Secondary UDI - DI | Text[120] | FlowField |
| placedOnTheMktCtryId | Text[120] | |
| Direct Marking UDI-DI | Text[120] | FlowField |
| PDLink | Text[50] | FlowField |
| ListofCMRSubstassociattoDevice | Integer | FlowField |
| Countriesthedevicesisavailable | Integer | FlowField |
| ListofCriticalWarnings | Integer | FlowField |
| Basic UDI-DI | Text[120] | FlowField |
| Clinical Sizes | Integer | FlowField |
| Intendedpurposeotherthanmed | Integer | FlowField |
| Nomenclature code | Integer | FlowField |
| annexXVIapplicable | Boolean | FlowField |
| Quantity of Device | Integer | |
| LabelledforpresenceofsubstCRM | Boolean | FlowField |
| Labelledofsubstendocrine | Boolean | FlowField |
| Containing latex | Boolean | |
| Maximum number of reuses | Integer | |
| New Device | Boolean | |
| OEMApplicable | Boolean | |
| ReferenceNumber | Text[120] | |
| Reprocessed | Boolean | |
| ReusesApplicable | Boolean | |
| SecondaryDIApplicable | Boolean | |
| SingleUse | Boolean | |
| Clinical Size Applicable | Boolean | FlowField |
| Sterile | Boolean | |
| Sterilization | Boolean | |
| StorageApplicable | Boolean | FlowField |
| TradeNameApplicable | Boolean | |
| WarningsApplicable | Boolean | FlowField |
| Website | Guid | |
| Additional Description | Guid | |
| Trade Name | Guid | |
| UDI-DI | Text[120] | FlowField |
| Related Legacy Device | Text[120] | FlowField |
| Relationship Type | Option | OptionMembers: None,Legacy-Regulation Device Link |
| Issuing Entity UDI-DI | Code[20] | FlowField |
| Issuing Entity Unit of Use DI | Code[20] | FlowField |
| Issuing Entity Secondary DI | Code[20] | FlowField |
| Iss. Entity Direct Marking DI | Code[20] | FlowField |
| ListofEndocrSubstasstoDevice | Integer | FlowField |
| ListofMedprodsubstasstoDevice | Integer | FlowField |
| ListofStorageandhandlingCond | Integer | FlowField |
| Device Status Date | Date | |
| Unit of Use DI Entry No. | Guid | |
| Secondary DI Entry No. | Guid | |
| Direct Marking DI Entry No. | Guid | |
| PDLink Entry No. | Guid | |
| Basic UDI-DI Entry No. | Guid | |
| Batch Number | Boolean | |
| Serialization Number | Boolean | |
| Manufacturing Date | Boolean | |
| Expiration Date | Boolean | |
| Software Identification | Boolean | |
| Base DI Entry No. | Guid | |
| Rel. Legacy Device Entry No. | Guid | |
| Rel. Legacy Issuing Entity | Code[20] | FlowField |