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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spacer, direct patient interface
Regulation Description Nebulizer.
Definition Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.
Product CodeNVO
Regulation Number 868.5630
Device Class 2

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