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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier nebulizer kit
Regulation Description Respiratory gas humidifier.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGG
Regulation Number 868.5450
Device Class 2

Device Problems
Connection issue 45
Break 10
Leak 9
Device operates differently than expected 9
Fitting problem 9
Failure to deliver 2
No flow 2
No Information 1
Melted 1
Detachment of device component 1
Hole in material 1
Failure to infuse 1
Total Device Problems 91

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 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Dec-12-2014

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