Manufacturing facility - the devices were manufactured at one of the two following manufacturing sites: availmed c.Industrial lt.001 mz.105 no 20905 int a, col cd ind.Tijuana, baja california 22444, mexico or baxter healthcare ¿ englewood 14445 grasslands dr englewood, co.80112 united states.The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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