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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device closed antineoplastic and hazardous drug reconstitution and transfer system
Regulation Description Intravascular administration set.
Definition Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Product CodeONB
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 4
Total Device Problems 4

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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