PTC UDI Domain
The UDI domain provides access to the UDI module of Windchill. The UDI module allows users to comply with the Part 830 medical device regulation for the UDI submission process. Users can electronically submit unique device identifiers for their medical devices and device packages to the Food and Drug Administration (FDA) Global Unique Device Identification Database (GUDID). Use the services provided by this domain to read the UDI super set data, and to create and modify the UDI super set objects. Users can add, remove, or modify the details present in the “table data” step of the UDI super set object. Users can update the UDI super set object based on the permission present in policy administration.
The following table lists the significant OData entities available in the UDI domain. To see all the OData entities available in the UDI domain, refer to the EDM of the domain. The domain EDM is available at the metadata URL.
Items
OData Entities
Description
UDI Super Sets
UDISuperSets
The UDISuperSets entity is created from the non-revisable UDI data. You can create, update, or read UDISuperSets.
UDI Super Sets 2
UDISuperSets2
The UDISuperSets2 entity is created from the revisable UDI data. You can create or read UDISuperSets2.
UDI Super Set ID
UDISuperSetId
The UDISuperSetId is used to identify a non-revisable UDI super set.
UDI Super Set 2 ID
UDISuperSet2Id
The UDISuperSet2Id is used to identify a revisable UDI super set.
UDI super set details
UDISuperSetDetail
The UDISuperSetDetail entity represents the detailed information for a UDI super set.
Packaging Configurations
PackagingConfigurations
The PackagingConfigurations entity represents UDI submissions and UDI templates.
PackagingConfigurations can be created, edited, and read for non-revisable UDI submissions, and edited but not created for UDI templates.
PackagingConfigurations can be created and read for revisable UDI submissions.
¿Fue esto útil?