UDI-DI Storage and Handling Conditions
According to the requirements for FDA & EU MDR, statements or instructions for the use of the product must also be issued on the UDI label. For this purpose, the Unique Device Identification app offers the possibility to store corresponding storage and handling conditions for each UDI-DI data record.
To enter the Storage & Handling Conditions, choose Related > Device Characteristics > Storage & Handling Conditions, or choose the No. of S&H Conditions field.
| Field | Description |
|---|---|
| Item No. | Specifies the item number that the record is linked to. |
| Variant Code | Specifies the variant code that the record is linked to. |
| Storage & Handling Type Code | Specifies a storage and handling type code used to pre-populate fields and to determine which symbol to print on labels. For more information, see UDI Storage & Handling Types. |
| Min. Value | Specifies the minimum value that must be met. |
| Max. Value | Specifies the maximum value that may be achieved |
| UDI Measure Unit Code | Specifies the UDI measure unit for the minimum and maximum values. |
| Special Condition Text | Specifies an additional, textual description for a special storage or handling condition that can also be printed on labels. For exports to GUDID, it is considered only if the UDI Measure Unit Code is set to TEXT SH. |
| Public Agency | Specifies the public agency this record is created for. Leave blank in order to apply to all public agencies. |
| Symbol Code | Specifies the symbol code assigned to the storage and handling type. You cannot add two storage and handling types that share the same symbol code. |
| EU S&H Condition Type | Specifies the condition type inherited from the symbol code. Only records with a populated value will be exported to EUDAMED as a storage and handling condition. |
| EU Critical Warning Code | Specifies the critical warning inherited from the symbol code. Only records with a populated value will be exported to EUDAMED as a critical warning. |
Note
The Storage and Handling Conditions can only be entered if the UDI-DI isn't marked as a Parent Package.
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