Unique device identification
Resmed's implementation of UDI labeling
Resmed adopted a 2D barcode, utilizing the GS1 Standards to comply with UDI requirements from the FDA. The 2D barcode provides greater flexibility than the 1D barcode used for our serial and catalog numbers.
1D barcodes
Resmed uses a Global Trade Identification Number (GTIN) to create the 1D barcode found on Resmed packaging. More than one GTIN number may exist for each catalog number. When a product undergoes a significant change, Resmed creates an additional GTIN for the corresponding catalog number.
Resmed provides lookup tables upon request for your inventory management systems. Refer to these tables to map catalog numbers to corresponding GTIN numbers. If you would like to obtain a current look up table, please email CustomerCare@resmed.com or call 1-800-424-0737.
2D barcodes
The 2D barcode provides greater flexibility than the 1D barcode used for our serial and catalog numbers. 2D barcodes require an image scanner that can read text both vertically and horizontally, which allows them to store more information. 1D barcode scanners can only read text horizontally.
Note: 2D barcode scanners can scan both 2D and 1D barcodes; however, 1D barcode scanners cannot read 2D barcodes.
What does the UDI system mean for you?
Integrating UDI into your inventory may lead to efficiencies. To learn more about the potential benefits of UDI labeling, visit the FDA website.
When will Resmed implement UDI?
FAQs
The FDA UDI Rule establishes a system to standardize and adequately identify medical devices through distribution, use and the supply chain, including hospitals and patients. The unique device identifier is a unique set of alphanumeric codes consisting of both a Device Identifier (company and product code) and a Production Identifier (specific manufacturing information). The UDI labeling must be readable to both machines (e.g. barcode, radio-frequency identification) and humans (text). Manufacturers must also populate a publicly accessible database, the Global Unique Device Identification Database (GUDID), with generic product information. The GUDID does not contain manufacturing information, such as serial numbers, for specific medical devices. The FDA UDI Rule applies to all medical devices sold in the US.
No. There are some products that do not have serial numbers, for example, masks, tubes and filter packs. These products will have a lot number listed in the UDI – all items produced within that same lot, will have the same UDI.
Yes.
The UDI will stay with the product from the time of manufacture and has the potential to be added to patients’ Electronic Health Records (EHRs).
UDI compliant labeling must appear on the primary packaging of a medical device. This includes carton or bag labels at the time of manufacture.
UDI compliant labeling must also appear on the medical devices themselves if they require reprocessing or sterilization between uses. This may be an applied label or directly marked on the medical device (e.g. laser etched).
For the machine readable component of the UDI, Resmed uses the GS1 DataMatrix 2D barcode. The data contained within the GS1 DataMatrix image is encoded to the full GS1 encoding system, using Application Identifiers (AIs) to separate the individual parameters.
For the Human Readable Interpretation (HRI) component of the UDI, this will appear adjacent to the 2D barcode with each parameter prefixed by its AI in parentheses “(…)”.
Yes. The UDI label will contain 1–5 fields of data depending on the product. The fields that contain information will always be in the same order as shown below. This is a requirement of the GS1 standards for UDI.
- Global Trade Identification Number (GTIN). The GTIN is a mandatory field, which describes Resmed as the labeler and includes the product code.
- Date of Manufacture
- Use By Date
- Lot/Batch Number
- Serial Number
No. All Resmed labels have the same information and barcodes used prior to the implementation of UDI labeling. The UDI labeling (2D barcode and/or the Human Readable Interpretation) is additional information.
It is an FDA regulation that all medical devices for sale in the US be labeled with a UDI. You can save time by scanning our new 2D barcode, where most of the information needed for your records is stored in one place. Most barcode scanners will automatically decode GS1 compliant barcodes. Find out more information about the GS1 Standards.
2D barcodes require a 2D imager. The data stored in a 2D barcode runs both horizontally and vertically, so only an imager (2D barcode scanner) can properly decode the information. A 1D barcode scanner will not be able to read a 2D barcode; however, a 2D barcode scanner can read a 1D barcode.
Please ensure you have a 2D barcode scanner. This scanner contains an imager that is necessary for scanning 2D barcodes. Most barcode scanners will automatically decode GS1 compliant barcodes. If you are uncertain if your barcode scanner is GS1 capable, please contact your barcode scanner supplier.
Unfortunately, not at this time.
Manufacturing information that forms part of the UDI will not be stored in the GUDID. It is intended that the UDI will be stored by each party in the supply chain.
The GUDID is a database administered by the FDA as part of the UDI system. The database, which serves as a reference catalog of information about medical devices with a UDI, will be publicly accessible to allow all stakeholders (provider systems, payers, clinicians, patients, industry, the FDA and others) to search, download and use generic information about the medical device. Find out more information about the GUDID.
The GS1 Standards include the use of Application Identifiers (AIs), which are multi-digit prefixes that identify the specific type of data. For example, when scanning a serial number/barcode, a “21” will appear before the actual serial number. This notifies any GS1 compliant scanner or system that the numbers after the “21” are a serial number and not a random set of numbers.
The GS1 Standards are used globally by manufacturing companies to ensure data captured from GS1 barcodes are unambiguous, and can electronically communicate this data to inventory management systems.
To learn more about GS1 in the healthcare industry, or about 2D barcodes and AIs, visit the GS1 website.
Most barcode scanners will automatically decode GS1 compliant barcodes. If you are uncertain if your barcode scanner is GS1 capable, please contact your barcode scanner supplier.
The Resmed product you are looking for in the GUDID may not yet need to be UDI compliant. It may also not be listed because it could also be within the time-frame between Resmed listing and publishing the product in the GUDID and the information becoming public. During this window, the product information may be updated by Resmed.
We can provide you the breakpoints for each product range. Please consult your customer service representative for more information.