Cruxi
Compliance research
FDA’s acquired field table treats storage/handling type, numeric bounds and unit as related fields. Once a type is added, at least one bound and the relevant unit are conditional; a single exact value uses both bounds. Special-storage text has its own condition. Source these values from approved product information, rather than inventing a range from a product name.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Observed FDA field relationships
FDA Data Elements Reference Table; acquired link labelled December 17, 2024. Entry conditions and edit rules below are transcribed from that version.
| Field | Recorded entry condition | Post-grace-period edit rule | Recorded new-DI trigger |
|---|---|---|---|
| Storage and Handling Type [1] | Optional | Add Delete Edit | No |
| Low Value [2] | Conditionally Required* *One value (Low or High) is required if Storage and Handling Type is added to the device record | Add Delete Edit | No |
| High Value [3] | Conditionally Required* *One value (Low or High) is required if Storage and Handling Type is added to the device record | Add Delete Edit | No |
| Unit of Measure [4] | Conditionally Required* *Required if Storage and Handling Type is added to the device record | Add Delete Edit | No |
| Special Storage Conditions [5] | Conditionally Required* *Required if 'Special Storage Conditions' is selected above | Add Delete Edit | No |
Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure.
Choose a value from the drop down LOV. Conditions of the Storage and Handling Type are measured below as a range, with a Low Value and a High Value. More than one Storage and Handling Type can be added per device record.
Data type: NA
Entry values: Refer to List of Values (LOV) sheet
Indicates the low value for storage and handling requirements.
Enter a number for Low Value. Must enter at least one value, Low or High but can enter both Low Value and High Value, if needed. When Storage and Handling value is a range, this is the lower end of that range When Storage and Handling value is not to fall below a minimum value, enter the number here When Storage and Handling value is exactly a value, enter the value here and in Storage and Handling High Value The low value can be up to 6 characters in length including leading zero, decimal and negative sign. Up to 4 numbers are allowed after the decimal.
Data type: Type: Num. Length: 6
Entry values: NA
Indicates the high value for storage and handling requirements.
Enter a number for High Value. Must enter at least one value, Low or High but can enter both Low Value and High Value, if needed. When Storage and Handling value is a range, this is the higher end of that range When Storage and Handling value is not to rise above a maximum value, enter the number here When Storage and Handling value is exactly a value, enter the value here and in Storage and Handling Low Value The high value can be up to 6 characters in length including leading zero, decimal and negative sign. Up to 4 numbers are allowed after the decimal.
Data type: Type: Num. Length: 6
Entry values: NA
The unit of measure associated with the storage and handling conditions.
Choose a value from the drop down LOV.
Data type: NA
Entry values: Refer to List of Values (LOV) sheet
Indicates any special storage requirements for the device.
Enter any other storage conditions. For devices kept at room temperature, or other standard conditions, input that information here.
Data type: Type: Alphanum. Length: 200
Entry values: NA
Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are ‘auto-populated’ fields whose information depends on another data element Note: The above do not apply if the device is “unlocked” for editing. For more information on “unlocking” device records for editing, please visit www.fda.gov/udi [6]
See 21 CFR 830.310 and 830.340 for required data elements. [7]
Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option. [8]
These are dated FDA reference-table fields, not an automated legal applicability assessment or validated submission. The AccessGUDID download schema is different from the FDA HL7 SPL submission implementation package. No quarantined schema is used.
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Extract the relevant temperature, humidity, pressure or special-storage statement from controlled product information.
Useful evidence: Approved labels/IFU and validated storage specification.
Separate minimum-only, maximum-only, bounded-range and exact-value cases using the source table’s entry rules; retain signs and units.
Useful evidence: Condition/type/bounds/unit worksheet and conversion rationale.
Check conditional special text and unsupported formatting before upload; investigate disagreement between artwork and master data.
Useful evidence: Reviewed exception list and label-to-record reconciliation.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
Mon, 16 Dec 2024 01:15:52 GMT · retrieved 2026-10-06
Source key D02 · snapshot f8318545152bce0733ec399fdae290591dc81d521958ea88d7f914e426703f57
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