FDA UDI-DI Card
On the FDA UDI DI Card, all relevant information and master data required by the FDA regarding to the UDI requirements is available.
For each Item or Item Variant card a corresponding UDI record can be created by choosing Item > FDA UDI-DI.
If the GTIN has already been entered in the GTIN field on the Item page and GS1 has been defined as the Issuing Agency in the UDI Setup, the GTIN is adopted as the DI number when the UDI data record is created. When creating the data record, the system checks whether the GTIN to be created is already used. If it is already used, there will be an error message and the system stops creating the FDA UDI-DI Data. For more information, see Generate GTINs.
Tip
Entries on several, subordinate pages are required. These pages can be accessed both through actions and drill-downs to fields that start with Number or No. in their names. It is best to edit all fields one after the other.
Fields
Certain fields are marked with a red asterisk. The red asterisk means that the field must be filled to complete a certain process that uses the field, such as releasing the FDA UDI-DI.
Tip
Choose the Toggle instructional texts action on the Actions menu to get additional note texts for FastTabs and groups of fields. You can remove them by choosing them again.
General FastTab
| Field | Description |
|---|---|
| Is Parent Package | Specifies whether the current DI is supposed to contain other DIs. If the toggle is turned on, specify the child DIs in the packaging lines. Parent package DIs require only very few information. They are not directly exported to GUDID, but indirectly by exporting the DIs they contain. |
| UDI Status | Specifies whether the UDI-DI is ready to be uploaded to the GUDID. |
| Blocking Date | Specifies the date on which the UDI Status was set to Blocked. |
| DI Record Publish Date | Specifies the date the DI Record was first published to GUDID and made available via public search. |
| Submission Set ID | Specifies the globally unique identifier for the device that will used by GUDID to link subsequent versions with previous versions. If you leave it blank, it will be automatically populated during release and should not be changed ever after. |
| Submission Version No. | Specifies an internal counter that is increased on every export to GUDID. |
| Exported DI No. | Specifies the value that the Primary DI No. was exported as. GTINs are exported with leading zeros until 14 digits are reached. |
| Created At | Specifies the date and time when the UDI-DI data were created. |
| Created By | Specifies the user who created the UDI-DI data. |
| Modified At | Specifies the date and time when the UDI-DI data were last modified. |
| Modified By | Specifies the user who last modified the UDI-DI data. |
DI Information FastTab
| Field | Description |
|---|---|
| Brand Name | Specifies the English proprietary/trade name of the medical device as used in the labeling or catalog. This information is mandatory. |
| Version or Model | Specifies the version or model number found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. |
| In Commercial Distribution | Specifies whether the device is currently offered for sale. This field is intended for internal use only, and it is not exported to GUDID. |
| Commercial Distribution End Date | Specifies the date the device is no longer held or offered for sale. The device may or may not still be available for purchase in the marketplace. |
| Catalog No. | Specifies the catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. |
| Device Description | Specifies the English description of the device. |
| Issuing Agency | Specifies the organization accredited by FDA to operate a system to issue UDIs for devices. |
| Primary DI No. | Specifies an identifier that is the primary lookup for a medical device. The primary DI will be located on label of the base package. For medical devices without packaging, the primary DI number and full UDI may be on the device itself. For more information, see Generate GTINs. |
| Device Count | Specifies the number of medical devices in the base package (the lowest package level of a medicinal device containing a full UDI). If the number is greater than one, at least a unit of use or a direct marking DI must be specified. |
| Labeler DUNS | Specifies the labeler company number issued by Dun & Bradstreet (D&B). It was initialized from the UDI setup submitter DUNS, but it may be updated to any other DUNS that is part of the GUDID account as labeler DUNS. |
| No. of FDA Listing Nos. | Specifies the number of 7-character listing numbers assigned by the FDA. At least one listing number is required for all medical devices, except for HCT/P, kits and licensed IVDs. Medical devices that are HCT/P products with a BL premarket number may not have listing numbers. |
Device Characteristics FastTab
| Field | Description |
|---|---|
| MRI Safety Status | Specifies the information the labeling contains about whether the device is compatible with magnetic resonance imaging (MRI) procedures. |
| Contains Natural Rubber | Specifies whether the device or packaging contains natural rubber that contacts humans. Natural rubber includes natural rubber latex, dry natural rubber, and synthetic latex or rubber that contains natural rubber. |
| Produced without Natural Latex | Specifies that natural rubber latex was not used as material in the manufacture of the medical product and container and the device labeling contains this information. Not all medical products that are NOT made with natural rubber latex are so marked. |
| For Single Use | Specifies that the device is intended for one use or on a single patient during a single procedure. |
| Prescription Use (Rx) | Specifies whether a prescription is required. |
| Over the Counter (OTC) | Specifies whether the device is sold over the counter. |
| Kit | Specifies a collection of products, including medical devices, that are packaged together to achieve a common intended use. |
| Combination Product | Specifies whether the product is comprised of two or more types of medical products, such as a drug and a medical device. |
| HCT/P | Specifies that the product contains or consists of human cells or tissues that intended for implantation, transplantation, infusion, or transfer into a human recipient. |
| No. of GMDN Codes | Specifies the number of Global Medical Device Nomenclature (GMDN) codes as device types. At least one code must be provided. |
| No. of FDA Product Codes | Specifies the number of 3-character products codes assigned by the FDA. At least one product code is required for all medical devices, except for kits and licensed IVDs (indicated by a premarket number beginning with BL). |
| Exempt from Premarket Submission | Specifies if an FDA premarket submission is not required for this device. It can be selected only if the device does not contain human tissue (HCT/P). |
| No. of FDA Premarket Submission Nos. | Specifies the number of premarket submission numbers assigned by the FDA. |
| Licensed IVD | Specifies whether the device is a licensed in vitro diagnostic product, as indicated by a premarket number beginning with BL. |
| Packaged as Sterile | Specifies whether the device is packaged to be free from viable microorganisms. |
| No. of Sterilization Methods | Specifies how many sterilization methods have been set up for the device. If at least one method is attached, GUDID interprets that sterilization is required prior to use. |
| No. of SH Conditions | Specifies how many storage & handling conditions have been set up for the device. |
| Clinical Sizes Category Code | Specifies the category of clinical sizes that the EU UDI-DI belongs to. Clinical sizes categories also contain any assigned attributes. |
Alternative and Additional Identifiers FastTab
| Field | Description |
|---|---|
| Is Parent Package | Specifies whether the current DI is supposed to contain other DIs. If the toggle is turned on, specify the child DIs in the packaging lines. Parent package DIs require only very few information. They are not directly exported to GUDID, but indirectly by exporting the DIs they contain. |
| No. of Parent Package DIs | Specifies the number of packaging units that contain the current package DI. Opens the UDI-DI Packaging Lines page. |
| Secondary Issuing Agency | Specifies the agency that issues the secondary DI number. It must differ from the primary issuing agency. |
| Secondary DI No. | Specifies an optional device identifier that may be an alternate lookup to the primary DI. |
| Unit of Use DI No. | Specifies a number of the same issuing agency as the primary DI number. |
| Direct Marking required | Specifies whether a direct marking is required. This internal information is not exported to GUDID. |
| Excepted from Direct Marking | Specifies if the device is subject to direct marking under 21 CFR 801.45, but is excepted. |
| Alternative DM DI required | Specifies whether an alternative direct marking DI is required. |
| DM Issuing Agency | Specifies the agency that issues the direct marking DI number. It may be the same as the primary issuing agency. |
| DM DI No. | Specifies the alternative direct marking DI number. |
| Lot or Batch No. | Specifies that the lot or batch number is required as part of the PI. The value is read from the item tracking code of the item the UDI-DI is attached to. |
| Serial No. | Specifies that the serial number is required as part of the PI. The value is read from the item tracking code of the item the UDI-DI is attached to. |
| Primary Tracking Identifier | Specifies which tracking numbers are used as part of the UDI-PI if both lot/batch and serial number tracking apply. The options are All Tracking Numbers, Lot Number, and Serial Number. This field can be edited only when the UDI Status field is set to Open and if both Lot or Batch No. and Serial No. fields are set to Yes. The value from this field is copied to Label Item Entries to be considered on label barcodes and is considered on UDI export. |
| Expiration Date | Specifies whether expiration date is required as part of the PI. |
| Manufacturing Date | Specifies whether the manufacturing date is required as part of the PI. |
| Donation Identification No. | Specifies for a HCT/P regulated device, whether the distinct identification code by 21 CFR 1271.290(c) is required as part of the PI. |
Customer Contact FastTab
The fields on the Customer Contact FastTab indicate how patients and consumers with device-related questions can contact the device company.
| Field | Description |
|---|---|
| Contact No. | Specifies the number of the contact who is responsible for this device. The contact number is not passed to GUDID. |
| Contact Name | Specifies the name of the contact who is responsible for this device. |
| Contact Phone No. | Specifies the phone number of the contact who is responsible for this device. The format should be in +0xx(xx)xxx format and cannot exceed 20 signs. |
| Contact E-Mail | Specifies the e-mail of the contact who is responsible for this device. |
Additional Classification FastTab
All fields of the Additional Classification FastTab are not relevant for the GUDID.
| Field | Description |
|---|---|
| Product Risk Class | Specifies the product risk class according to 21 Code of Federal Regulations. |
| Measurement Function | Specifies that the device has a measurement function. |
| Active | Specifies whether the device is an active device. |
| Implant | Specifies whether the device is an implant. |
| Reusable Surgical instrument | Specifies whether the device is a reusable surgical instrument. |
| Reprocessed | Specifies whether the device is a reprocessed device. |
| Contains Medication | Specifies that the product contains a medication. |
| Contraindication Text | Specifies the product's contraindication. |
Labels FastTab
Here data is stored which controls the printing of data and symbols on labels. They are not relevant for GUDID.
| Field | Description |
|---|---|
| Label Layout Code | Specifies which layout will be considered when printing a label for the current UDI-DI. |
| Importer Contact No. | Specifies the number of the contact who imported this device. The contact number is not passed to GUDID. |
| Distributor Contact No. | Specifies the number of the contact who distributed this device. The contact number is not passed to GUDID. |
| Country of Manufacture | Specifies a two letter or three letter country code to be printed as a symbol on labels. If no code is specified, the symbol will not be printed. |
| Date Symbol | Specifies whether to print the date symbol on labels. |
| Liquid Filter Pore Size | Specifies the value to be printed as a symbol on labels, e.g., 15 µm. If no value is specified, the symbol will not be printed. |
| No. of Additional Symbols | Specifies the number of additional or electrical symbols to be printed on labels. |
Field Values & Dependencies
Some fields are considered mandatory because of the value of another field. The table below lists the most important dependencies.
| Field / Value | Description of Dependencies |
|---|---|
| Unit of Use | If the Device Count > 1, the Unit of use needs to be filled. |
| Exempt from Premarket Submission | If a premarket submission is linked to the FDA UDI-DI data, the field value cannot be set to Yes. |
| Donation Identification No. | If HCT/P = Yes the Donation Identification No. needs to be filled. |
| Direct Marking | If a direct marking is necessary for a device, the following dependencies exist: Direct Marking = Yes Excepted from Direct Marking = No Alternative DM DI required = Yes DM Issuing Agency - Needs to be filled DM DI No. - Needs to be filled |
| Secondary Issuing Agency | If a secondary DI No. is needed, the secondary issuing agency needs to be different from the primary issuing agency. |
Actions
The actions on the FDA UDI-DI Card are described in the following table.
| Menu | Action | Description | |
|---|---|---|---|
| Release/Reopen/Block | Release | Releases the UDI-DI to allow export. You must reopen the UDI-DI before you can make changes to it. | |
| Reopen | Reopens the UDI-DI to change it after it has been released. Exported UDI-DIs have the Released status and must be opened before they can be changed. | ||
| Block | Blocks the UDI-DI to avoid any further changes or exports. | ||
| Export | Create GUDID export file | Creates and downloads a GUDID export file. | |
| Actions | Copy from Item | Copies FDA UDI-DI values and related tables from the item that the variant is attached to. The action is visible only for UDI-DIs attached to item variants. | |
| Copy from UDI-DI | Copies FDA UDI-DI values and related tables from another FDA UDI-DI. The action is visible only for non-parent FDA UDI-DIs not attached to item variants. | ||
| Actions | Generate GTIN | Assigns a new GTIN to the Primary DI No. field. For more information, see Generate GTINs. | |
| Toggle instructional texts | Shows/hides additional note texts for FastTabs and field groups. | ||
| Related > DI Information | Brand Names | Opens the UDI-DI Brand Names page where existing brand names can be viewed or new brand names can be edited. The entry of the brand names is language code dependent and depends on the respective public agency to which the data set is to be exported. Therefore, it is possible to enter both FDA or GUDID relevant brand names as well as EUDAMED relevant brand names. | |
| FDA Listing Nos. | Opens the FDA Listing Nos. page where existing FDA Listing No. can be viewed or new FDA Listing No. can be edited. | ||
| Related > Device Characteristics | GMDN Codes | Opens the UDI-DI GMDN Codes page where existing GMDN Codes can be viewed or new GMDN Codes can be edited. For more information, see UDI GMDN Codes. |
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| FDA Product Codes | Opens the FDA Product Codes page where existing FDA Product Codes can be viewed or new FDA Product Codes can be edited. For more information, see FDA Product Codes. |
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| FDA Premarket Submission Nos. | Opens the FDA Premarket Submission Nos. page where existing FDA Premarket Submission Nos. can be viewed or new FDA Premarket Submission Nos. can be edited. | ||
| Sterilization Methods | Opens the UDI Sterilization Methods page where existing sterilization methods can be viewed or new sterilization methods can be edited. For more information, see UDI Sterilization Methods. |
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| Storage & Handling Conditions | Opens the UDI-DI Storage & Handling Conditions page where existing storage and handling conditions can be viewed or new storage and handling conditions can be edited. | ||
| Clinical Sizes | Opens the Clinical Sizes page where existing clinical sizes can be viewed, or new clinical sizes can be edited. The Clinical Sizes gives Information about the Size Type, the Attributes and belonging Size Values. | ||
| Related > Alternative and Additional Identifiers | Packaging Lines | Opens the UDI-DI Packaging Lines page. This action is only available if the Is Parent Package toggle is turned on. | |
| Related > Labels | Print Label Preview | Prints a label preview based on the current UDI data, and using dummy item tracking data. The Label Layout Code must be specified. | |
| Additional Symbols | Opens the UDI-DI Symbols page. Here you can maintain additional or electrical symbols that are to be printed on labels. This data is not relevant for GUDID. | ||
| Related > History | Show Change History | Opens the Change Log Entries page which is filtered to the belonging Basic UDI-DI Date Item. The page shows all Changes of that Basic UDI-DI Data, which should be recorded. All changes are displayed with date and time stamp, user ID, table description, field description, type of change, old value and new value. The action is only active if change log entries exist. |
Clinical Sizes FactBox
The Clinical Sizes FactBox displays the UDI-DI related clinical sizes. The clinical size relevant attributes and related values are displayed in the FactBox. Choose the Edit action of the FactBox to directly edit the belonging clinical sizes attributes and values.
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