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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gastrointestinal tubes with enteral specific connectors
Regulation Description Gastrointestinal tube and accessories.
Definition To facilitate enteral specific connections.
Product CodePIF
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
ZEVEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 15
Difficult to advance 6
No Known Device Problem 2
Material integrity issue 1
Detachment of device component 1
Fluid leak 1
Migration of device or device component 1
Occlusion within device 1
Total Device Problems 28

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

Recalls
Manufacturer Recall Class Date Posted
1 MOOG Medical Devices Group II Dec-14-2015
2 Xeridiem Mediem Medical Devices Inc II Feb-26-2016

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