Device Identification List

The Device Identification (DI) list displays a list of device identifiers related to the selected product.

To access this:

  1. From Product Properties of a medical device product, click the Regulatory category.

    For more information, see Product Line user's guide: Working with Products: Product Properties Page.

  2. Click the Device Identification page tab.
  3. From the page toolbar, Select Active or All to list the device identifications that are active or all.

This page discusses:

See Also
Device Identification Home Page

Columns

The following columns are present below the Regulatory Information header.

Column Name Description
Name Name of the DI device identification object. Click to view its details.
Revision The revision of the DI.
State State of the DI object. Possible states are Draft, Review, Approved, Submitted, and Published.
Country Code of country in which the product is distributed commercially.
Region The region in which the DI is created.
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.
DUNS Number The DUNS number of the DI.
Product Line The product line in which the DI is connected.
Model The model in which the DI is connected.
Part The part which is added to the DI.
Description The description of the DI.

Actions

Action Description For More Information
> Generate GTIN This generates the GTIN for the DIs that are selected. It also sets the Issuing Agency to GS1. _
> Reference DI Lets you add the existing DI and remove the added refrence DI.
  • Add Existing - Adds the existing DI to the context DI as reference.
  • Remove - Removes the added the refrence DI.
 Adding Reference Device Identification.
> 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:
  • You must provide information in all the mandatory fields in the Device Information page, Device Status page, and the Device Characteristics page.
  • You must create at least one package device identifier and one contact with the type as Manufacturer.
 --
> Publish to Authority Generates 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 device identification object must remain associated with the medical device.
  • You can delete only the device identification objects that you own.
--
> Validate Device Lets you validate the selected DI. The validation report is displayed according to the regualtory authority for which the context DI is created. The report lists all the validation that are need to complete. -
Edit Lets you edit the details of the selected DI. Modifying Device Identification Details.
Summary Report Lets you generate the summary of the DI. You can save the report as pdf and html format. Summary Report.
Insert new row Lets you insert the rows above or below of the selected row.
Note: This option is enabled in the Edit mode. When you enter the row, add the details in the related columns and the DI is added with the required details.
 Creating a Device Identification.
Remove inserted row(s) Lets you remove the inserted rows. -