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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blanket, neonatal phototherapy
Regulation Description Neonatal phototherapy unit.
Definition Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
Product CodePDH
Regulation Number 880.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONX
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1

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 Beevers Manufacturing & Supply, Inc. II Aug-10-2014

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