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Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

The subject device is a tamper evident female luer lock cap intended for use with male luer ports on syringes. Covering luer fittings on syringes helps reduce the risk of touch contamination and medication leakage. The user group consists of those involved in pharmacy compounding as well as health care professionals. The subject device's clear outer shell/housing provides tamper evidence if the cap or the contents of the container is tampered with prior to clinical administration. Once removed, the shell/housing cannot be replaced back onto the luer cap, thus making it obvious if someone has previously attempted to remove the cap and/or attempted to tamper with the contents of the syringe. The subject TrueCare Biomedix Tamper Evident Cap is packaged in a bulk pharmacy tray with 25 caps per tray and is provided sterile via ethylene oxide sterilization.