KVSKBAUDIBasicUdi
Summary: Stores and manages UDI Basic Udi records, including Base DI Issuing Entity, Entry No., and Released.
Fields
| Name | Type | Note |
|---|---|---|
| Base DI Issuing Entity | Code[20] | FlowField |
| Entry No. | Guid | |
| Released | Boolean | |
| Internal Version | Integer | |
| Active | Boolean | |
| Transferred | Boolean | |
| Description | Text[100] | |
| No. of Exports | Integer | FlowField |
| Legal Manufacturer SRN | Text[15] | |
| Applicable Legislation | Option | OptionMembers: None,MDR,IVDR,MDD,AIMDD,IVDD |
| MultiComponent Device Type | Code[20] | |
| Base DI Code | Text[120] | FlowField |
| Authorised Representative | Text[15] | |
| Animal Tissues/Cells | Boolean | |
| Clinical Investigation | Boolean | FlowField |
| Device Model Applicable | Boolean | |
| Human Tissues/Cells | Boolean | |
| Active Device | Boolean | |
| Administer/Remove MedProduct | Boolean | |
| Implantable | Boolean | |
| Measuring Function | Boolean | |
| Reusable Surgical Instruments | Boolean | |
| Companion Diagnostic | Boolean | |
| Microbial Tissues/Cells | Boolean | |
| Near Patient Testing | Boolean | |
| Patient Self Testing | Boolean | |
| AR Comments | Integer | FlowField |
| Device Certificate Information | Integer | FlowField |
| Clinks | Integer | FlowField |
| Human Blood/Plasma | Boolean | |
| Medicinal Substance | Boolean | |
| DeviceModel | Text[255] | |
| DeviceName | Text[255] | |
| Medical Purpose | Guid | |
| Reagent | Boolean | |
| Professional Testing | Boolean | |
| Instrument | Boolean | |
| Exempt frm ImpltblDev Rgultion | Boolean | |
| SpecialDeviceType | Code[50] | |
| Base DI Entry No. | Guid | |
| Device Risk Class | Text[50] |