The quantity is as follows: Lumin LM3000- 509 cartons containing 4 units per carton (2,036 units total). The following claims were on the box of the Lumin LM3000: UV Multi-Purpose Sanitizer, Hospital Strength, Kills 99.99% Human Corona-virus 229E, and The Lumin LM3000 bioburden Reduction UV System is also effective with COVID-19 and inactivates the SARS-CoV-2 virus on N95 respirators. Consequently, the distribution of a misbranded device is an unlawful act under FIFRA Section 12(a)(1)(F), 7 U.S.C. Section 136j(a)(1)(F). Therefore, this entry must be denied pursuant to Section 17(c) of FIFRA 7 U.S.C. Section 136o(c). Finally, the Notice of Arrival of Pesticides and Devices was not filed on EPA Form 3540-1 in accordance with 19 C.F.R. ? 12.112. Failure to file a report required by the Act is a violation of FIFRA Section 12(a)(2)(N), 7 U.S.C. Section 136j(a)(2)(N).