CA Proposition 65
California residents please be advised of the following, pursuant to Proposition 65:
WARNING: The medical devices and product mentioned in this website may contain chemicals known to the State of California to cause cancer, birth defects and other reproductive harm. While certain Nonin Medical products may contain detectable amounts of some of the identified chemicals, our products meet the requirements under the U.S. Food, Drug, and Cosmetic Act for safety and effectiveness. The biological safety of Nonin products has been established based upon internationally recognized standards.
Unique Device Identifier (UDI)
Beginning in January 2015, Nonin Medical initiated labeling changes to include Unique Device Identifier (UDI) information and barcodes on product labels per new U.S. Food and Drug Administration (FDA) GS1 Healthcare standards. During the transition to the UDI label format, you may see a mixed inventory of product labeling, but both formats will include all existing Nonin Medical label data. All container labeling will be transitioned to include UDI information and barcodes by the FDA’s Class II Medical Device mandated date of September 24, 2016. All product labeling will be transitioned to add UDI information and barcodes by September 24, 2018.
For more information view our UDI FAQ
US Federal Sunshine Act Statement
Section 6002 of the US Affordable Care Act added section 1128G to the Social Security Act (the Act), which requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under title XVIII of the Act (Medicare) or a State plan under title XIX (Medicaid) or XXI of the Act (the Children’s Health Insurance Program, or CHIP) to report annually to the Secretary certain payments or other transfers of value to physicians and teaching hospitals.
Specifically, manufacturers of covered drugs, devices, biologicals, and medical supplies (applicable manufacturers) are required to submit on an annual basis certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year.
“Payment or other transfer of value” is defined broadly as “a transfer of anything of value.” This includes all payments or other transfers of value given to a covered recipient, regardless of whether the covered recipient specifically requested the payment or other transfer of value. In addition, payments or transfers of value made to an individual or entity at the request of or designated on behalf of a covered recipient must be reported under the name of the covered recipient.
You should be aware that certain activities between Nonin Medical, Inc. and healthcare professionals and teaching hospitals may be required to be reported under this so called “Sunshine Act.”