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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device regulator, vacuum
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeKDP
Regulation Number 880.6740
Device Class 2


Premarket Reviews
ManufacturerDecision
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 2
Device operates differently than expected 1
Increase in suction 1
Suction issue 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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