Device Identification Home Page

When you select Device Identification from the north quadrant of the Compass, the Device Identification home page and menu appear. The home page lists device identification objects that you own or for which you are a task assignee.

This page discusses:

See Also
Device Identification List
Product Identifications

Columns

Section Column Name Description
Name Name of the DI device identification object. Click to view its details.
Revision The revision of the DI.
Regulatory Information State State of the DI object. Possible states are Draft, Review, Approved, Submitted, and Published.
Submit Status Status of the regulatory submission.
  • : Submitted to the regulatory authority and awaiting acknowledgment
  • : Submission failed
  • : Submission successful
Publish Date Date on which the device identification is published, after this date the DI information is available for public search.
Country Code of country in which the product is distributed commercially.
Region The region in which the DI is created.
Class Risk classification of the medical device. Device class varies with country and region.
Note: This column is not present when you access the DI from the Devices tab of an ASPI.
Issuing Agency Name of the issuing agency.
DI Number Unique identifier given to a medical device to identify it when it is in distribution and use. Primary DI is displayed on the base package of the medical device.
Owner Name of the owner of the DI object.

Filters

Based on your role, you can filter the device identifications by ownership or state.

The following filters are available for Leader, Product Managers, and Regulatory Leads.

  • Active: Lists the device identification objects that are not in the Published state and for which the user is the creator or owner.
  • Assigned: Lists the device identification objects for which the user is a task assignee.
  • Published: Lists the device identification objects that are in the Published and Superseded state and for which the user is the creator or owner.
  • For Publish: Lists the device identification objects that are in the selected For Publish state and for which the user is the creator or owner.

In addition, the For Publish filter is available only for Regulatory Leads. This filter lists the device identification objects that are in the Review or the Approved state, and are owned by other users.

For task assignees, the device identification objects that are assigned through tasks are displayed.

Actions

The Actions are not present when you access the DI from the Devices tab of an ASPI.

Action Description For More Information
> Generate GTIN Generates the global trade item number (GTIN) if the issuing agency is selected as GS1. Generating GTIN
> Clone Creates a copy of the selected device identification object. All details except the primary DI number are copied.
Note: The selected objects must be in the Draft state or the Review state.
Cloning a Device Identification.
> Submit To Review Promotes selected device identification objects from the Draft to the Review state. --
> Submit To Approved Promotes selected device identification objects from the Review to the Approved state.
Notes:
  • Provide information in all the mandatory fields in the Device Information page, Device Status page, and the Device Characteristics page.
  • Create at least one package device identifier and one contact.

To promote from the review to the Approved state, the following dependent objects must be in the valid states as given below.

Object State
Product Line Complete
Model Active
Products Release
Contact Active
Market Authorization Release
Market Authorization Change Closed
Package Product Frozen

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> Publish to Authority Generates the submission file for the selected device identification object and submits it to the regulatory authority. Submitting Device Identification to Regulatory Authority Through AS2 Gateway
> Delete Deletes the selected device identification objects.
Notes:
  • The selected objects must be in the Draft or the Review state.
  • All device identification objects cannot be deleted. At least one DI object must remain associated with the medical device.
  • You can delete only the device identification objects that you own.
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Summary Report Creates summary report of the selected device identification object. Summary Report
> Accept Lets you take ownership of the selected device identification objects that must be published to regulatory authority.
Notes:
  • You must be a Regulatory Lead.
  • You can accept objects that are displayed when you select the For Publish filter.
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> Transfer Ownership Transfers the device identification object to the required user. Transferring a Device Identification