GUDID Device record history

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#1
Can someone please help me to understand this data submitted to GUDID by manufacturer. I think there are mistakes or am I just confused? I am attaching screenshots. It says Device count 1. In GMDN it says it's biliary stent, in FDA product code it says NIP which is a code for superficial femoral artery stent. FDA code for biliary stent is FGE.
So my first question when this dismatch of codes is possible/acceptable?

In Additional Identifiers it states there is no Unit of use DI. When I go to Device record history in public versions 2 and 3 it shows there is unit of use DI 10705032025055 and device count is 2. In public version 4 there is no unit of use and device count is 1.
How is that it stated on the device page that device count is 1 and no units of use and in the history it shows there was unit of use and device count was 2 and in the final version it was changed to no units of use and device count 1? In what situations this is possible? How the unit of use disappeared?

I am just learning so all of this looks to me as errors but maybe it's because of lack of knowledge. Please help to understand.
 

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#3
Can someone please help me to understand this data submitted to GUDID by manufacturer. I think there are mistakes or am I just confused? I am attaching screenshots. It says Device count 1. In GMDN it says it's biliary stent, in FDA product code it says NIP which is a code for superficial femoral artery stent. FDA code for biliary stent is FGE.
So my first question when this dismatch of codes is possible/acceptable?
Sometime this happens when there is no suitable GMDN code available. In that situation the manufacture tries to find the nearest possible code which describe their device. I am not familiar with the said device, but I assume this is the reason why they used this GMDN code even though it doesn't match with the FDA product code. When I used the keyword "femoral artery stent", the closest I could find was the term "Drug-eluting femoral artery stent". Perhaps, the said device (S.M.A.R.T.) does not have a "drug-coating" and so the manufacturer avoided this GMDN term.
In Additional Identifiers it states there is no Unit of use DI. When I go to Device record history in public versions 2 and 3 it shows there is unit of use DI 10705032025055 and device count is 2. In public version 4 there is no unit of use and device count is 1.
How is that it stated on the device page that device count is 1 and no units of use and in the history it shows there was unit of use and device count was 2 and in the final version it was changed to no units of use and device count 1? In what situations this is possible? How the unit of use disappeared?
This type of scenario is allowed when the manufacturer decided that it was a typo in their device count and did not actually alter the packaging. The reason why I assume it was a typo, because change in the device count usually triggers a "new DI" while change in the Unit of Use DI does not trigger "New DI". So, I guess, before placing the device into the market (and after the DI records were published) the manufacturer decided it was a typo and hence changed the information without having a new DI. And since the device count is <2, so there is no question of placing any Unit of Use DI.

These are my wild guesses, I hope I am able to clear your doubt to some extent.
 
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