Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

UDI Requirements - Products that all fall under the same family

jkc3usc

Involved In Discussions
#1
A UDI is composed of two parts:
  • Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.
  • Production Identifier(s) (PI)
So my question is if I am medical device manufacturer and I make a product that all fall under the same family. An example a Toyota Camry, but may contain different options (color, accessories, options, etc). Or can the one DI cover all Toyota cars? Do I need a DI then for each one that is different. Or is the DI an umbrella for the one product and all its options. The PI would then be used to tell the rest?

Thanks
 

jkc3usc

Involved In Discussions
#2
A UDI is composed of two parts:
  • Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.
  • Production Identifier(s) (PI)
So my question is if I am medical device manufacturer and I make a product that all fall under the same family. An example a Toyota Camry, but may contain different options (color, accessories, options, etc). Or can the one DI cover all Toyota cars? Do I need a DI then for each one that is different. Or is the DI an umbrella for the one product and all its options. The PI would then be used to tell the rest?

Thanks
Also does the Class of device make it easier? Anyone have a class 1 label created I could see as an example? or anyone have knowledge on class 1 udi labeling
 
#3
Hi guys! I found a complete guideline for Unique Device Identification system (UDI system) Application Guide from IMDRF group.
Go to IMDRF webpage www imdrf org and look for IMDRF Documents.
 

jkc3usc

Involved In Discussions
#4
Also I read that a UPC can be used instead of UDI for class 1. It may be easier just to use a UPC and not go the UDI route. Any thoughts?
 
Top Bottom