UDI Barcode Labels
Class I, II and III UDI bar code labels printed to your specifications - FDA Compliant
UDI compliance is currently mandatory for all Class III medical devices and quickly becoming mandatory for Class II. WePrintBarCodes can help you sort out the complexities.
From 1,000 to 1 million, WePrintBarcodes.com is your source for top quality UDI barcode labels.
New FDA UDI labeling requirements for Class II Medical Device manufacturers is fast approaching the September 24, 2016 deadline.
Don't risk non-compliance, WePrintBarcodes.com has the expertise to guide you through the myriad of options and complexities.
We offer a variety of sizes and options and can print 1D or 2D barcodes depending on your specific product requirement.
In a hurry? No problem, most orders ship the same day, and remember UPS ground freight is always FREE at WePrintBarcodes.com.
 | REST ASSURED!
Every barcode label we print is put through a rigorous grading process called barcode verification. Our labels are guaranteed unconditionally and we will gladly replace any label that does not scan correctly.
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Common Questions and Answers:
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The UDI number is a unique numeric or alphanumeric code. It includes a device identifier (DI), which is specific to a device model, and may include a production identifier (PI). The production identifier includes the current production information for that specific device, such as the lot or batch number, the serial number, expiration date or a combination.
The first step in UDI compliance is to contact one of the three issuing agencies to be assigned a UDI number.
The three issuing agencies are:
Once you have been assigned your UDI number it is the manufacturers responsibility to go to FDA website and maintain your data in the FDA GUDID (Global Unique Device Identification Database) - gudidsupport@FDA.hhs.gov
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As shown in the diagram below, there are three basic styles of UDI labels. Selecting the proper UDI label will greatly depend on your product and FDA requirements.
As you can see all of the varieties are made up of a series of application identifiers (AI) and data bits. Different products will require different sets of AI's and associated data.
This diagram does not represent an exhaustive list of application identifiers. A complete list can be found here. GS1-128 Application Identifiers
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- Our labels are guaranteed to scan and are verified throughout the run for quality.
- Our labels are printed on thermal transfer barcode printers which are the standard for high quality barcode label printing.
- Our labels are die cut with rounded corners and gaps between labels for easy removal.
- Our labels come on rolls not sheets so they are easier to handle and store.
- Each roll is shrink-wrapped for protection against dirt and grime.
- Each roll is labeled with the amount and a sample label for easy inventory.
- Our labels are on 1.5" cores for easy handling and storage.
- We package all rolls using recycled packaging paper and heavy duty boxes to ensure your labels arrive safely.
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Our standard high quality paper label is perfect for most uses however, certain applications require a synthetic label. Synthetic labels are useful for many applications because the label is water and weatherproof. In addition synthetic labels don't have a "memory" like paper labels so they are perfect for application on a curved surface.
Synthetic labels are also perfect in an industrial or harsh environment.
We use polypropylene synthetic labels. The finest quality you can purchase.
If your application will be subjected to moisture or chemicals we suggest printing your UDI barcode labels on our synthetic polypropolene stick.
