H10: the actual device was available for evaluation.The visual inspection of the actual products showed them dry and out of the original packaging.Polyurethane residual (potting material) in the dialysate port was visible for all the products, however, this is not a failure.This is due to the potting process a pur- film can occur inside the hansen connector.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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