Hi Covers,
Is the supplemental oxygen produced by a portable oxygen concentrator (prescription required) considered a drug? I am trying to determine the software level of concern and one of the questions is whether or not the device is used with a drug. The device filters air and concentrates the oxygen for delivery to patient via a nasal cannula. It is not life supporting. Is the oxygen in this case considered a drug per FDA? The concentrator device is Class II (product code CAW) if that helps-
Anyone worked on something similar?
Thx!
Is the supplemental oxygen produced by a portable oxygen concentrator (prescription required) considered a drug? I am trying to determine the software level of concern and one of the questions is whether or not the device is used with a drug. The device filters air and concentrates the oxygen for delivery to patient via a nasal cannula. It is not life supporting. Is the oxygen in this case considered a drug per FDA? The concentrator device is Class II (product code CAW) if that helps-
Anyone worked on something similar?
Thx!
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