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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cuff, tracheal tube, inflatable
Regulation Description Inflatable tracheal tube cuff.
Product CodeBSK
Regulation Number 868.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
POSEY
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to zero 8
Decrease in pressure 6
Other (for use when an appropriate device code cannot be identified) 5
Pressure, insufficient 4
Unknown (for use when the device problem is not known) 3
Component missing 2
Component(s), broken 2
Fire 2
Loose 1
Break 1
Total Device Problems 34

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 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

Recalls
Manufacturer Recall Class Date Posted
1 H & H Associates I Oct-01-2013

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