In this mdr, bd corporate headquarters in (b)(4), nj has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.Returned to manufacturer on: unknown.(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Device manufacture date: unknown.Bd received the instrument from the customer facility for investigation.The instrument was evaluated and the customer's indicated failure mode with the incident lot was not observed.
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