Information Page

This page displays the details of a device identifier (DI). It displays DI information, additional identifiers, and commercial distribution details.

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

To access this page:

  • View the Device Information page. For more information, see Device Information.
  • From the page, click the Information tab.

This topic describes:

This page discusses:

See Also
Opening a Device Identification Object

Fields

Field Name Description
Owner Name of the device identification object owner.
Originator Name of the person who created the device identification object.
Policy The policy that governs the lifecycle of the product.
State State of the device identification object. Possible states are Draft, Review, Approved, Submitted, and Publish.
Originated Date when the device identification object was created.
Modified Date when the device identification object was last modified.
Country Country code of the country in which the product is distributed commercially.
Region The region in which the product is distributed.
Class Risk classification of the medical device. The class varies with country.

You can submit class I, class II, and class III devices to the regulatory authorities.

Issuing Agency Organization that issues the DI. Issuing agencies are organizations that are recognized by the regulatory authority to issue DIs. Possible values are GS1, HIBCC, and ICCBBA.
DI Number Unique identifier given to a medical device to identify when it is in distribution and use. Primary DI is displayed on the base package of the medical device.
Previous DI Issuing Agency DI issuing agency of the previous organization
Previous DI Number DI number of the previous organization
Device Count Number of medical devices in the base package.
Unit of Use DI Number Virtual identifier assigned to medical device when DI is not labeled on unit of use level. This is applicable if the base package contains more than one unit. It helps identify the use of a specific device on a patient.
DUNS Number Data Universal Numbering System (DUNS) business number issued to the labeler by Dun & Bradstreet (D&B).
Brand Name Proprietary name, trade name, or brand name of the medical device that is displayed on the device label or catalog. The brand name is obtained from the product line details.
Version Or Model Number Version or model number that is displayed on the device label or packaging. It is used to identify the category or design of a device. The model number is obtained from the model details.
Catalog Number Catalog number, reference number, or product number that is displayed on the device label. It is used to identify a specific product.
Description Additional information about the medical device.
DI Record Publish Date Date on which the DI is published. After this date the DI information is available for public search.
Grace Period The time period allocated for DI modifications after the publish date. The grace period starts after the DI is published and ends after specific calendar days. The revised DI need to be resubmitted within the grace period. For more information, see About Grace Period.

Following are the status of DI grace period:

  • Not applicable - The DI is not submitted and published and so, grace period is not applicable.
  • Not started- The DI is submitted to the authority, but not published. So grace period has not started.
  • Within- The DI is published and the grace period has started. The expiry date of grace period is given in the DI preferences.
  • Expired- The expiry date of grace period is crossed and so grace period is expired.

Commercial Distribution End Date Date after which the device is not be held or offered for sale. The device is not be available for purchase after this date.
Commercial Distribution Status Indicates whether the device is in commercial distribution.
Device Subject to Direct Marking, but Exempt Indicates if the device is exempt from direct marking requirements under Code of Federal Regulations - Title 21 (21 CFR) 801.45.
DM DI Different from Primary DI Indicates if the direct marking (DM) DI is different from the primary DI number.
DM DI Number Identifier marked directly on the device. It is different from the primary DI. It is applicable only for devices that are subject to DM requirements under 21 CFR 801.45.
Approvers Lists the persons or route template details who are part of the review process of the DI. For more information, see Approvers of DI.
Automatic submission to Authority

Yes: When the you click Publish To Authority, the submission file is created and sent to the regularity authority.

No: When the you click Publish To Authority, the submission file is created but is not sent to the regularity authority. You must download the file and send it manually to the regulatory authority.

Intended Market The indended market for the DI.
Originally Placed On Market The market in which the DI is released.
Note: The Intended Market and Originally Placed On Market options are only present for the DI that is created in the EU region.
Message Id Message ID received from the regulatory authority.
Core Id Core ID received from the regulatory authority.
Regulatory Response Details from the acknowledgment received from the regulatory authority after the DI is submitted.
Submit Status Acknowledgment status received from the regulatory authority.

Actions and Toolbar Commands

Action Description For More Information
> Revise Creates a revision for the DI. The revised DI has the same DI number with one added to the previous DI. The first revised DI is with revision one and on revising it, new DI is created with revision two and so on.

Only a Product Manager can revise a DI. Only some attributes of a DI can be changed during the revision.

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> Transfer Ownership Transfers the device identification object to the required user. Transferring a Device Identification
Clone Creates a copy of the selected device identification object. All details except the primary Clone 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 the device identification object from the Draft state to the Review state. --
> Submit To Approved Promotes the device identification object from the Review state 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.

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

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

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> 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
> 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. -
Summary Report Generates a summary report for the selected device identification object. Summary Report
Edit Activates edit mode that lets you modifies the details of the device identification object. Modifying Device Identification Details