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The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, Pro Health Care Nasal Oxygen Cannula, has been issued an FDA Certificate of Medical Device Registration to the Market Authorization Holder (MAH), VMED Medical Company, in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2022-1815 dated 26 October 2022 is hereby lifted.

The public health warning imposed on the remaining product listed in FDA Advisory No. 2022-1815 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.         

To report any sale or distribution of unnotified medical device, contact the online reporting facility, eReport, through e-mail at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

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