Disposable Component

Disposable Component. Means an attachment for devices (A) CMS markets for the assessment of nutritional needs, metabolism, aerobic performance, or cardiac output, (B) which is directly contacted by a user's breath during a test and is intended to be replaced between uses for hygienic purposes, and (C) the manufacture or sale of which does not require premarket approval by the FDA under the United States Federal Food, Drug, and Cosmetics Act.

Disposable Component. Means an attachment for devices CMS markets for the assessment of nutritional needs or cardiac output, and which is directly contacted by a user's breath during a test and is intended to be replaced between uses for hygienic purposes.