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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

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