The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Symbols - Device label versus Packaging label

Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Some Related Topic Tags
iso 15223 - medical device label symbols, labels and labeling (general), medical devices, packaging labeling and related requirements, symbolization for devices
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 14th June 2018, 04:34 PM

Total Posts: 91
Question Symbols - Device label versus Packaging label

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.

Sponsored Links
  Post Number #2  
Old 14th June 2018, 04:50 PM

Total Posts: 22
re: Symbols - Device label versus Packaging label

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.

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission? eyalhend Other ISO and International Standards and European Regulations 1 18th December 2016 07:17 AM
Medical Device Packaging Label Validation RCW Other US Medical Device Regulations 5 27th September 2016 09:34 AM
Recommendations for Label Printer / Label Stock for On-Device Labels yodon 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4 12th August 2013 04:32 AM
IFU (Instructions for Use) Label Symbols Requirements karha096 EU Medical Device Regulations 16 18th February 2013 08:56 AM
IVD Label Symbols - IVD with Human Serum as Control - Biohazardous? Eugenia CE Marking (Conformité Européene) / CB Scheme 1 17th October 2011 03:51 AM

The time now is 12:44 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"