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On September 24, 2013, the United States Food and Drug Administration (FDA) released a final rule requiring that most medical devices distributed in the United States carry Unique Device Identifiers (UDI). The UDI system facilitates medical device identification, traceability, and tracking through distribution and use. The rule requires that product information pertaining to the devices be submitted to the FDA’s Global Unique Device Identification Database (GUDID).
In addition, the rule also requires that a new, standardized date format be placed on all medical device labels.
Masimo has updated our labeling for compliance with the UDI regulation and GS1 Standards.
If you have questions beyond the scope of these FAQs, please contact Customer Service:
US: firstname.lastname@example.orgOutside US: email@example.com
A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters based on a global coding standard that adequately identifies a device at the point of distribution and at the point of use. A UDI is composed of:
Masimo uses GS1 as their accredited agency for assigning barcodes and barcode structures.
Please note that any product that is NOT classified as a medical device is not required to contain a barcode.
All medical device companies must comply with the UDI regulations.
** Masimo is voluntarily direct part marking all reusable products. Masimo products are not required to be direct marked per the current FDA ruling.
Masimo distributes Class II and a few Class I products. Masimo has updated our labeling for compliance with the UDI regulation and GS1 standards.
Below are examples of:
Please Note: Depending on type of product, the label will contain one of two dates. For products that have a “Use By” date, it will appear as YYYY-MM-DD beneath the expiration symbol, and will also be encoded as YYMMDD preceded by the production identified (17) within the GS1 and 2D barcodes. For products that do not have a “Use By” date, the Date of Manufacture will appear as YYYY-MM-DD adjacent to the date of manufacture symbol and also be encoded as YYMMDD preceded by the production identifier (11) within the GS1 and 2D barcodes.
Sensor Box Label Examples
Sensor and Cable with Direct Part Marking Examples
A GTIN is a globally unique GS1 Identification Number used to identify a "trade item." GTINs are assigned by the brand owner (labeler) of the product and are used to identify products as they move through the global supply chain to the end user, such as a hospital. If you are not currently using the GS1 system with GTINs to manage your products, you will need to obtain the GTINs for the products you are purchasing.
For more information about GTINs, please contact GS1 at: https://www.gs1us.org/what-we-do/standards.
Email Masimo Customer Service:
Please include your customer ID and the product part number(s) in the email.
Yes. The LOT or REF barcodes on the label will be removed and replaced with text and can no longer be scanned. For LOT information, you will either scan the GS1 barcode or locate it next to the LOT symbol on the label. The REF information can be identified in the corresponding GTIN. For more information on GTINs, see question #6 above.
No, Masimo product numbers will remain the same.
The UDI rule adopted the standardized date format YYYY-MM-DD on device labels. Dates on labels will be in the new format no later than the date on which the label of the device must bear a UDI. For more information on the implementation timeline, see question #3 above.
The GUDID is a publicly searchable database that contains the device identification (DI) portion of the UDI for every medical device as well as other required product information. All medical device companies must submit DI information to the GUDID. Masimo has started populating the GUDID and will ensure that all products are added according to or in advance of the UDI implementation timeline.
No, there are two exceptions for existing inventories:
No. The rule only requires direct marking for reusable medical devices that need to be reprocessed (high level cleaning/sterilization) before reuse.
Masimo is voluntarily direct part marking all reusable products. Masimo products are not required to be direct marked per the current FDA ruling. For more information on the direct marking implementation timeline, see question 3 above.
For more information on the UDI system, visit Unique Device Identification (UDI) on the FDA website:
If you have additional questions about how Masimo is complying with UDI regulations, please contact Masimo Customer Service at: