Regulatory Statements for D'OXYVA
For United States Residents Only
Circularity Healthcare operates a state-of-the-art supply chain and Quality Management System (QMS) for manufacturing. Circularity has a certificate of registration to IS EN ISO13485:2012 (European Union) and ISO13485:2003 under CMDCAS (Canada) it has been implementing since 2013.
D'OXYVA® (deoxyhemoglobin vasodilator) is a CE-marked medical device (Class I, low risk) in certain markets for delivery of liquid medications via the skin. Circularity is seeking approvals via the U.S. FDA and in other countries for delivery of Medical Gases such as Medical or Pharmaceutical Carbon Dioxide (UN1013) via a novel patented and patent-pending non-invasive transdermal route with D'OXYVA as treatment for various widespread conditions.
Medical or Pharmaceutical Carbon Dioxide is manufactured and delivered under applicable standards per each country's regulatory requirements. In the United States, the Food and Drug Administration (FDA) has cleared the use of Medical and Pharmaceutical Carbon Dioxide for the route of inhalation for humans but not yet for transdermal delivery with D'OXYVA. Transportation of Medical or Pharmaceutical Carbon Dioxide via any postal or courier service requires certification for handling Dangerous Goods (HAZMAT) by the U.S. Department of Transportation (DOT). Use of unapproved substances and products may be illegal, cause serious injury and even death!
Circularity Healthcare's platform biotech solution, D'OXYVA is utilizing the well-known GMP-compliant medical-grade Carbon Dioxide approved by regulatory agencies worldwide for use in the inhalation route like anesthesia as a non-toxic pharmaceutical substance. D'OXYVA enjoys an investigational device exemption (IDE) status and according to a recent review by the U.S. FDA in February of 2016, it requires no clearance of any kind for being marketed as a non-invasive transdermal delivery system of carbon dioxide to improve microcirculation.
Medical Gases intended for use in the United States are considered drugs by the U.S. FDA. Medical gases (e.g., oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and 49 combinations of these) are drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) and pursuant to section 503(b)(1)(A) of 51 the Act are required to be dispensed by prescription. Compressed Medical Gases (CMG) are any liquefied or vaporized gas alone or in combination with other gases which is a drug as defined by Section 201(g)(1) of the Act. As such, establishments that manufacture or process Medical Gases are considered drug manufacturers. Therefore, Medical Gas Establishments are subject to U.S. FDA drug registration and listing requirements
Ask your physician before using D'OXYVA FOR MEDICAL AND CLINICAL RESEARCH PURPOSES, prescription only. The D'OXYVA transdermal delivery device holds a growing number of Class I (low risk or non-significant risk medical device) licenses around the world. Use for non-medical purposes is available over-the-counter (OTC) and in various retail stores online and offline. Circularity's novel D'OXYVA patented transdermal drug delivery pathway with Medical Carbon Dioxide (UN1013) has not been evaluated yet by the U.S. Food and Drug Administration (FDA) and is not intended to diagnose, treat, cure, or prevent any disease. The information provided herein is for educational and research purposes and is not intended to replace medical advice. Individual results may vary.
Medical Carbon Dioxide Safety Information
CAUTION! CONTENTS UNDER PRESSURE. DO NOT PUNCTURE OR HEAT ABOVE 120 DEGREES FAHRENHEIT OR 49 DEGREES CELSIUS. DO NOT STORE IN AN ENCLOSED VEHICLE. DO NOT INHALE. DO NOT DISCHARGE TOWARDS BODY. KEEP OUT OF REACH OF CHILDREN.
CARBON DIOXIDE UN1013 NON-FLAMMABLE GAS 2
Rx only. WARNING: Administration of Carbon Dioxide may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Carbon Dioxide and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.
CAUTION: HIGH PRESSURE LIQUID AND GAS, CAN CAUSE RAPID SUFFOCATION. CAN INCREASE RESPIRATIONS AND HEART RATE. MAY CAUSE FROSTBITE. Avoid breathing gas. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. Cylinder temperature should not exceed 52° C (125° F). Use with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).
FIRST AID: IF INHALED , remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
IN CASE OF FROSTBITE, obtain medical treatment immediately.
DO NOT REMOVE THIS PRODUCT LABEL
I have more questions - who can I contact?
You may contact the United States Food and Drug Administration (FDA) with any questions or complaints you may have at 1-888-463-6332 or at the following website:
Contact U.S. FDA. We are available and happy to talk with you about any complaints you may have about our products and their effects. Chat online now, call your Sales Representative or call our Customer Service TOLL FREE at 1-855-5DOXYVA (1-855-536-9982) or at your own cost at 1-626-244-8090 or email us at firstname.lastname@example.org or email@example.com and typically we will respond within one business day.
Updated: January 3, 2018