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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, nitric oxide delivery
Regulation Description Nitric oxide administration apparatus.
Product CodeMRN
Regulation Number 868.5165
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOTHERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  GRANTED 1

Device Problems
Alarm, audible 1
Device Issue 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 1 0 0 0 0 0
Class II 0 0 0 0 0 0 0 2 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 INO Therapeutics (dba Ikaria) II Jan-23-2017
2 INO Therapeutics (dba Ikaria) II Feb-27-2015
3 INO Therapeutics (dba Ikaria) II Dec-12-2014
4 INO Therapeutics (dba Ikaria) II May-02-2014
5 Ikaria Holdings I Aug-13-2010
6 Ino Therapeutics I Jan-11-2012

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