Rx Purchase Requirements
Prescription Device — Rx Only
Rx Only. Federal law restricts this device to sale by or on the order of a practitioner licensed by law to use or order the use of the device.
The MIRARI® Cold Plasma System is a prescription medical device and is not available for unrestricted purchase by the general public.
Purchase is subject to verification of the purchaser's eligibility and, where applicable, professional or institutional credentials.
Who May Purchase
Orders for the MIRARI® Cold Plasma System may be accepted only from purchasers legally eligible to purchase or order the device under applicable law and GVI's applicable distribution policies.
Depending upon the purchaser and sales channel, GVI may require verification of:
- Professional healthcare license
- National Provider Identifier ("NPI")
- Healthcare practice or facility information
- DME/DMEPOS supplier information or credentials, where applicable
- Institutional purchasing authority
- Business identification information
- Other documentation reasonably necessary to verify purchaser eligibility
DME/DMEPOS credentials and an NPI may be required by GVI for designated DME sales or reimbursement channels but are not represented as the basis of the FDA prescription-device restriction.
GVI reserves the right to request additional documentation and to decline, suspend, or cancel an order when eligibility cannot be verified.
Order Acceptance
Submission of an order request does not constitute acceptance. General Vibronics, Inc. ("GVI") may verify purchaser credentials before accepting or fulfilling an order and may reject, suspend, or cancel an order if eligibility cannot be verified or if fulfillment would not comply with applicable federal or state law. An order is accepted only when GVI issues a written order acceptance.
Authorized Use
The MIRARI® Cold Plasma System must be used in accordance with its current FDA-cleared labeling, Instructions for Use ("IFU"), warnings, precautions, contraindications, and other manufacturer instructions.
Information provided on this website is for product, professional, educational, and commercial informational purposes and does not replace the Product's labeling or IFU or the independent clinical judgment of an appropriately licensed healthcare practitioner.
Nothing on this website is intended to expand or modify the FDA-cleared indications for use of the MIRARI® Cold Plasma System.
Individual patient results may vary.