Symbols - Device label versus Packaging label

#1
Hi everyone,

I have a labeling question. A company declares conformity to ISO 15223 for symbols to used with medical device labels. The information on the device packaging label (the outer packaging that protects the device during shipping) however does not show all the symbols on the device itself except for the following symbols: temperature, humidity, keep dry, fragile, and pressure. Also, the name of the device is generic on the packaging label without the model number that appears on the device. Can somebody tell me what the difference is between device label and the packaging label? They also export to US, and a separate UDI number is generated for the packaging label. Therefore, why are the symbols on packaging label not consistent with the device label? Thank you.
 
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#2
What you refer to as a 'packaging label' is considered to be a shipping container for the purposes of this law. Shipping containers do not require the UDI. The barcodes on shipping containers can be one of several standards (not regulated by the FDA at this time) but the trend is toward a code 128 linear barcode called an SSCC, serialized shipping container code. This is a unique barcode that links to the EDI ASN (advanced ship notice) regarding the shipment, including the manifest typically.

Hope this helps! You can contact us if you have barcode related questions on either UDI or DSCSA.
 
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