Additional information was received for h3, h4, h6, and h10.H4: device manufacture date: the lot was manufactured from february 15, 2023, to february 16, 2023.H10: the actual device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.The flow rate was set at 5ml on the multirate control module of the device and a functional flow rate test was performed.The results were found to be within the product specification range.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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