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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered fecal management system
Definition A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment.
Product CodeSJB
Regulation Number 876.5230
Device Class 2


Premarket Reviews
ManufacturerDecision
CM TECHNOLOGIES, INC.
  GRANTED 1

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