H4: device manufacture date: the lot was manufactured from november 11, 2021 to november 12, 2021.H10: the actual device was returned for evaluation.A functional flow test was performed, and the flow rates were found to be within the product specification.The reported condition was not verified.The sample was determined to be a conforming product.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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