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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
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
BIONIX DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Beevers Manufacturing & Supply, Inc. II Aug-10-2014
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