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

FDA Class 1 Medical Device UDI requirements

I have not found much information on Class 1 minimum requirements. I know the UDI contains the DI and PI but to what extent. Also we make product that could have a blue color, or a red, or a green, does that mean I need a separate UDI for all different colors and options? Just seems overkill if it still all under the same product family. Does anyone have an example or could send me in the right direction?
Per the regs the PI is not required for class 1 devices. We use the GS1 website to generate the UDI number, that 14 digit number is all that is required as far as UDI goes no lot/batch numbers are included in the machine readable code. You can generate barcodes via the GS1 website. We do alot of nitrile gloves and we have been generating UDI for each size and different colors. We generate UDI for each individual SKU with is pretty easy using the Gs1 mass upload feature.
Top Bottom