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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reusable intermittent urinary catheter system
Definition A reusable intermittent urinary catheter system consists of a reusable intermittent urinary catheter inserted through the urethra into the bladder for urine drainage and the components necessary to reprocess the intermittent catheter. The reusable intermittent urinary catheter can be reused after reprocessing (e.g., cleaning and disinfection) with the components necessary to reprocess the intermittent catheter. The system may include cleaning and microbicidal agents, lubricant and disposable components. The reusable intermittent catheter and any reusable reprocessing components are intended for single patient reuse.
Product CodeSHV
Regulation Number 876.5120
Device Class 2


Premarket Reviews
ManufacturerDecision
CATHBUDDY, INC.
  GRANTED 1

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