UDI Information Page
The UDI information page provides tools for managing the details and collection of information associated with UDIs. The page has menu actions and tabs for managing information about the UDIs. On the Actions menu, you can perform various actions on UDIs.
Tabs
The following tabs are available on both FDA UDI and UDI Super Set information page:
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Tab
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Description
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Details
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The FDA UDI submission Details tab contains following sections:
• The General section displays the general FDA UDI submission information.
The UDI Super Set Details tab contains General section which displays the general UDI Super Set information.
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The UDI Super Set Details tab does not contain Transmission Details section.
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Related Information
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Displays the related product and related template to UDI.
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History
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Displays the version history of UDI.
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Routing/Process History
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Displays the UDI process status and task history.
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Members
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Displays information about the UDI roles. The Members table provides action to add and manage members for UDIs. Assign the UDI Approver, UDI Creator, or Library Manager roles, depending on the role the user should be assigned to. For more information, see Members Table. |
Actions
The UDI information page contains a list of menu actions available from the upper left area of the page. The availability of these actions depends on the workflow status of the UDIs, as well as your access to it.
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Actions
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Description
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Rename
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Allows you to modify the name and other attributes of UDI.
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Set State
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Create Follow Up
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Allows you to create a new iteration of the UDI. After creating a follow-up task, the new iteration of the UDI undergoes through the same lifecycle to be submitted to the regulatory agency.
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Link to Part
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Allows you to link UDIs to a part. The UDIs can only be linked to one part.
If the UDI is already linked to a part, this action is not visible.
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Edit Access Control
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Edit Security Labels
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Allows you to view and change the security label values. If you have required permissions, you can change the security label values that are in place for the UDI.
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Undo Reservation
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When this action is enabled, it indicates that another user has the UDI reserved for modification. You can use this action to manually revoke their reservation and allow another user to modify the object.
A confirmation message appears with details about the user and the action they are performing.
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This action is only available to site and organization administrators.
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See
Actions Common Among Objects for a list of common actions available in Windchill.
On the FDA UDI Details page, the Transmission Details table contains the following information:
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The following section does not apply to UDI Super Set.
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Column
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Description
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Attempt
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Number of submission attempts.
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Transmission Status
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The status of the UDI submission (for example, successful, delayed, failed, or submitting).
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View HL7
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Click the XML icon  to view the HL7 report in XML format. |
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Acknowledgement 1 Receipt Date
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The date the system received the first acknowledgement from the FDA.
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Acknowledgement 2 Receipt Date
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The date the system received the second acknowledgement from the FDA.
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Acknowledgement 3 Receipt Date
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The date the system received the third acknowledgement from the FDA.
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Delayed Comment
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If the submission was delayed, information from the Delayed Comment field appears here.
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Communication ID
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A value assigned by the communication delegate when the submission was sent to the FDA. This is a unique identifier within the AS2 server.
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Message ID
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A value assigned by the AS2 server to uniquely identify the submission to the FDA. This value is included in Acknowledgement 1.
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Core ID
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A value assigned by the FDA to uniquely identify the submission. This value is included in Acknowledgement 2.
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To view additional details, click the acknowledgement details icon
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UDI Transmission Acknowledgements, you can view the following information:
Column | Description |
Number | Number of submissions. |
Transmission Status | The status of the communication with the FDA. It can be submitting, successful, or failed. |
Message Summary | A summary of the error message returned by the FDA, if applicable. |
Date Received | The date the system received the acknowledgement from the FDA. |
FDA Message Report | System messages from the FDA. |
Under Acknowledgement 3 Errors, if the transmission failed or was delayed, you can view error messages to see why the transmission failed or was delayed. If the transmission was successful, no error messages appear.
| You can also view the UDI status in the State column of the Folder Contents or My Tasks table. |
