TrueCare Biomedix Tamper Evident Cap

TrueCare Biomedix Tamper Evident Cap is an FDA 510(k)-cleared medical device (K210818) manufactured by Us Infusion Inc. D/B/A Truecare Biomedix-USA. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2021. Regulation: 8.