UDI Setup
The UDI Setup page contains all the necessary configurations for COSMO Unique Device Identification. The UDI Setup page is accessed using Tell Me. Choose the 
icon, enter UDI Setup, and then choose the related link.
On the general setup page, general configurations are set which are required in the context of the UDI master data and marking processes.
On opening the UDI Setup page, some fields are set by default but can be adjusted as needed.
General FastTab
The general required setup fields are described in the following table.
| Field | Description |
|---|---|
| Issuing Agency | Specifies the default issuing agency for new UDI-DIs. Can be updated on each UDI-DI individually. |
| Importer Contact No. | Specifies the default importer contact number for new UDI-DIs. Can be updated on each UDI-DI individually. |
| Distributor Contact No. | Specifies the default distributor contact number for new UDI-DIs. Can be updated on each UDI-DI individually. |
| Check Permission for UDI Status | Specifies whether users need a special setup on the UDI Status Permissions page to change the UDI Status of UDI-DIs. |
| GS1 Company Prefix | Specifies a numeric, 7- to 9-digit GS1 Company Prefix. It is used to generate GTINs for items, variants, and UDI-DIs, and to calculate GMNs for basic UDI-DIs. For more information, see Generate GTINs. |
| GTIN Nos. | Specifies the number series that will be used to generate GTINs for items, variants, and UDI-DIs. The value is considered only if the field is not specified on the item level. The assigned numbers can have a maximum length of 13 minus the GS1 Company Prefix length. For more information, see Generate GTINs. |
| Activate FDA Appl. Area | Specifies whether FDA controls shall be displayed (see App Activation). Refresh the page after a change. |
| Activate EU Appl. Area | Specifies whether EU controls shall be displayed (see App Activation). Refresh the page after a change. |
| Skip Export Data Update | Specifies whether file exports for UDI-DIs should skip updating any fields. When enabled, export files are generated normally but no changes are made to UDI-DIs (e.g., Submission Version No., Version No., Exported DI No.). This setting is intended for testers and developers to verify export file contents and should never be enabled in production environments. |
FDA FastTab
The fields in the FDA FastTab only need to be maintained if you manage FDA UDI-DIs and want to send them to the GUDID.
| Field | Description |
|---|---|
| Customer Contact No. | Specifies the default contact for new UDI-DIs. Can be updated on each UDI-DI individually. |
| Customer Contact Name | Specifies the name of the default contact (read-only). |
| Sender DUNS | Specifies your labeler or third-party DUNS number that is part of your GUDID account. It will be used as the default labeler DUNS for new UDI-DIs. For UDI-DIs not labeled by yourself, the labeler DUNS can be updated on each UDI-DI individually. |
| English UDI Language Code | Specifies the UDI Language Code that represents the English language. It is required for exports to the FDA GUDID. |
EU FastTab
The fields in the EU FastTab only need to be maintained if you manage EU UDI-DIs and want to send them to the EUDAMED database.
| Field | Description |
|---|---|
| Model Reference Nos. | Specifies the code for the number series that will be used on GS1 global model number (GMN) calculation for basic UDI-DIs. The assigned numbers may have a maximum length of 23 minus GS1 company prefix length. |
| Our Manufacturer SRN | Specifies the single registration number (SRN) provided by EUDAMED to act as a manufacturer. |
| Our SPP Producer SRN | Specifies the single registration number (SRN) provided by EUDAMED to act as a system or procedure pack (SPP) producer. |
| Default XSD Version | Specifies the default XSD version number. It is used to export to EUDAMED, unless a custom XSD version is populated. |
| Custom XSD Version | Specifies the custom XSD version to replace the default XSD version. Enter the value in the same format as the default XSD value. |
Labels FastTab
Print labels using reports or connect to a label software. For more information, see Labels Overview.
| Field | Description |
|---|---|
| Use Legacy HTTP Request Management | Determines whether the old or new HTTP Request Management is used. - For installations prior to the 5.2 release, turning off this toggle will enable the HTTP request management using the Rest Client module. Once turned off, it cannot be turned back on. - For installations using the 5.2 release or later, the new HTTP request management is used and this setting cannot be changed. With the new HTTP Request Management, whenever printing UDI labels or communicating with the label software, the application generates HTTP requests using the standard Rest Client module. This provides enhanced security and communication error message handling. |
| HTTP Timeout | Specifies the duration in milliseconds to wait before an HTTP request times out. If none is specified, the Business Central default timeout of 100 seconds is used. In the cloud, you can set a maximum value of 5 minutes (300,000 milliseconds). |
| Default Layout GS1 | Specifies the default label layout for GS1 UDI-DIs. |
| HIBC LIC | Specifies the 4-digit, alphanumeric Labeler Identification Code (LIC) assigned by the HIBCC. It identifies the labeler on HIBC barcodes. |
| Default Layout HIBCC | Specifies the default label layout for HIBC UDI-DIs. |
| Label Public Agency | Specifies from which public agency UDI data will be fetched on UDI label print. If not specified, the user will be prompted to choose the public agency individually on every print (unless reprinting from the UDI Label Entries page, or the document to print involves only UDI-DIs of the same public agency). |
| COSMO Barcode Auth. Method | Specifies which authentication method the COSMO barcode requires. |
| COSMO URL Barcode | Specifies the COSMO URL to return a barcode image for reports. Additionally, set an authentication key by choosing More options > Actions > Labels > COSMO Barcode. |
| Label Software Usage | Specifies whether and how label software is used for printing. For values other than None, a corresponding API URL must be provided. Possible values: - None: Printed using reports - Print: Labels are printed on printers of the label software. - Preview: Returns the labels as PDF files. The printer setup is irrelevant for this. - Print Job: For test purposes only. Returns the printer specific data. For more information, see Set up Label Printing. |
Actions
| Menu | Action | Description |
|---|---|---|
| Home | UDI Status Permissions | Opens the UDI Status Permissions page to set up permissions for changing UDI Statuses. |
| Information | About | Shows the current product version and copyright information. |
| Actions | Labels > COSMO Barcode Labels > Label Software |
Opens submenus to manage label-related actions. For more information, see Set up Label Printing. |
| Insert Default Codes | Inserts default symbol codes, sterilization method codes, size types, and measure units. Existing codes will not be updated. | |
| Related | Information > Company Information | Opens the Company Information page to set up your company details. |
| App Licensing > License Overview | Opens the COSMO License Overview page, which lists the license status of the COSMO app and allows you to register the app and perform other administrative licensing tasks. For more information, see App Licensing and Registration. |
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