Systems for Serial Numbers, Batches and Catalogue Numbers

M

mr.mike

#1
Hi Everyone,

Wondering if anyone can chime in on systems for tracking device serial-numbers (unique identifier), lot/batch codes, and catalogue (ref/part) numbers?

My query is specifically related to labelling.
We want to comply with European MDD regs, as well as FDA CFR21.

So, as far as I gather the label should include:
- date (year) of manufacture
- device identifier (model)
- unique-identifier (serial)

Now, due to restricted space (the device is small), it is not feasible to include all this info separately - with the EN980 Manufacture-Date, REF & SN symbols.

So, my question is this: is it acceptable to combine all this information into a single, one-line serial number?

For example: SN-2012-TM10-1001-400234
Where: '2012' is the year of manufacture, 'TM10' is the model, '1001' is the batch, and '400234' is a unique-identifier.

Anyone else had any experience combining required information into a single serial-number like this?

Discussion always appreciated!:)
MM.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Systems for serials numbers, batches and catalogue numbers

Hi Everyone,

Wondering if anyone can chime in on systems for tracking device serial-numbers (unique identifier), lot/batch codes, and catalogue (ref/part) numbers?

My query is specifically related to labelling.
We want to comply with European MDD regs, as well as FDA CFR21.

So, as far as I gather the label should include:
- date (year) of manufacture
- device identifier (model)
- unique-identifier (serial)

Now, due to restricted space (the device is small), it is not feasible to include all this info separately - with the EN980 Manufacture-Date, REF & SN symbols.

So, my question is this: is it acceptable to combine all this information into a single, one-line serial number?

For example: SN-2012-TM10-1001-400234
Where: '2012' is the year of manufacture, 'TM10' is the model, '1001' is the batch, and '400234' is a unique-identifier.

Anyone else had any experience combining required information into a single serial-number like this?

Discussion always appreciated!:)
MM.
Hi,

A bit difficult to say without knowing what the device is.

In general, there are some provisions for transferring label info to the next immediate packaging level, for lack-of-room reasons. I tend to think that if on top of that you DO provide this info on the device (in some decipherable format) you should be OK. In such a case I'd recommend including in the IFU an explanation on how to parse the code on the device itself.

Cheers,
Ronen.
 
M

mr.mike

#3
Re: Systems for Serials Numbers, Batches and Catalogue Numbers

Thanks Ronen!

Yes, this was the intention: to include in the IFU a section describing the makeup of the serial-number (i.e. how to derive the manufacture year, model, and batch).

I was curious if this (condensing a bunch of info into a single serial-number) is an acceptable practice, is all.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Systems for Serials Numbers, Batches and Catalogue Numbers

Thanks Ronen!

Yes, this was the intention: to include in the IFU a section describing the makeup of the serial-number (i.e. how to derive the manufacture year, model, and batch).

I was curious if this (condensing a bunch of info into a single serial-number) is an acceptable practice, is all.
Just to clarify: The IFU explanation and condensed version on the device itself may be acceptable IN ADDITION TO the full details on the immediate next packaging level, not instead. All subject to what it actually is and all relevant circumstances.
 
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