Regulatory Open Forum

Background:

We sell a case packed with 100 units of Device A and 10 units of Device B. The Case is assigned a DI as well as Device A and Device B.

In GUDID, when we enter data, I enter Primary DI= DI for Device A, Package DI= DI for the case, which contains DI of Device A. (note - there is no way to indicate that this case contains Device B also)

Now, I create another record with Primary DI= DI for Device B, try to enter Package DI= DI for the case (to show the relationship with Device B and the Case), but the database gives an error message that “The DI already exists”.

Questions:

1. How would you enter this data in GUDID?
2. Since users can look up Device A, Device B or the Sales Pack in GUDID, is it necessary to show in the GUDID the relationship between the sales pack, Device A and Device B?

The idea of a packaging configuration is that it contains multiple quantities of the base package, and only the base package.

You will need a Primary DI for the base package of Device A, a Primary DI for the base package of Device B, and a Primary DI of the case. The case gets its own Primary DI, not a Package DI and, as a result, needs its own DI Record.

Consider the case as a kit. The contents of the case is 1, since it is one kit. Describe the contents of the case in the Device Description field.