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For the purposes of the device pass-through evaluation process, CMS evaluates the nominated device that is the subject of an application, not a category of devices, to determine if the device meets the eligibility criteria described in 419.66

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Most often, this is hypoglycemia a decrease in sugar below the 3.5 mmol/l mark

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The lipotropic agents (methionine, inositol, choline) are pH-sensitive and oxidise rapidly once exposed to air and moisture, which is why the 72-hour window exists rather than the 28-day stability window you'd see with straight methylcobalamin

10.1159/000510300 Neonatology