Regulatory Open Forum

My question is about quantity per package in GUDID. The GUDID Data Elements Reference Table states that quantity per package must be greater than 1. However, we have a product that contains 1 base device, packaged in 1 pouch, which is then packaged in 1 box. We currently place the UDI on the box label and pouch label. Is it okay to put a Quantity per Package of 1?

Thanks!

In your case, you don’t have a packaging configuration. This is intended for the situation where you might have five devices in a carton. Then the Package DI Number would be the next lower packaging level and the Quantity per Package would be 5.

You have a “1 in a 1”, which is not a packaging configuration. Leave that section blank for the situation you describe.

My question is about quantity per package in GUDID. The GUDID Data Elements Reference Table states that quantity per package must be greater than 1. However, we have a product that contains 1 base device, packaged in 1 pouch, which is then packaged in 1 box. We currently place the UDI on the box label and pouch label. Is it okay to put a Quantity per Package of 1?

Thanks!

Thanks Dan! So in this scenario, we would really only need the UDI on that box level, correct?

In your case, you don’t have a packaging configuration. This is intended for the situation where you might have five devices in a carton. Then the Package DI Number would be the next lower packaging level and the Quantity per Package would be 5.

You have a “1 in a 1”, which is not a packaging configuration. Leave that section blank for the situation you describe.

My question is about quantity per package in GUDID. The GUDID Data Elements Reference Table states that quantity per package must be greater than 1. However, we have a product that contains 1 base device, packaged in 1 pouch, which is then packaged in 1 box. We currently place the UDI on the box label and pouch label. Is it okay to put a Quantity per Package of 1?

Thanks!

My question is about quantity per package in GUDID. The GUDID Data Elements Reference Table states that quantity per package must be greater than 1. However, we have a product that contains 1 base device, packaged in 1 pouch, which is then packaged in 1 box. We currently place the UDI on the box label and pouch label. Is it okay to put a Quantity per Package of 1?

Thanks!

Hi Brandon,

My company just released prepackaged sterile devices that are also 1 device per pouch, 1 pouch per box.  Our interpretation led us to match the UDI for the device with the pouch (unit of measure 0, quantity 1, since this is representative of what's inside), then the box was labeled with unit of measure 1, quantity 1, since this is the secondary packaging.  We've been told this is sufficient, but there are so many interpretations flying around right now we're still trying to get a handle on best practices.

Additionally, we have a non-sterile part with a unit of measure 0, packaged in both quantities of 1 and 4.  With the UDI ruling, it's been very difficult trying to pinpoint how best to label these.  The parts inside the pouch are still unit of measure 0, but if we label the pouches differently (q1 for singles, q4 for 4packs), then the UDI on the pouch is not representative of the individual device inside.  If anyone has any insight on how best to move forward with this, I would be grateful.

Thanks

My question is about quantity per package in GUDID. The GUDID Data Elements Reference Table states that quantity per package must be greater than 1. However, we have a product that contains 1 base device, packaged in 1 pouch, which is then packaged in 1 box. We currently place the UDI on the box label and pouch label. Is it okay to put a Quantity per Package of 1?

Thanks!