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CHAPTER 24 - Devices
SUBJECT: Oxygen Equipment Emergency and OTC Use
POLICY:
Oxygen equipment intended for emergency use can be
marketed for OTC distribution. Such equipment must deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes. Labeling for emergency oxygen for OTC use may not contain references to heart attacks, strokes,
shock or any other medical condition amenable to diagnosis or treatment only by a licensed practitioner .
Oxygen units delivering a minimum flow rate of less than 6 liters of oxygen per minute for a period less than 15 minutes and labeled for emergency use are
considered adulterated and misbranded.
If the units are not intended for emergency use and provide less than 6 liters/minute or are labeled for human use for other than emergency use, such
units are regarded as prescript ion devices and must bear the prescription legend.
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