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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury
Definition For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).
Product CodeQZV
Device Class 3


Premarket Reviews
ManufacturerDecision
SEASTAR MEDICAL
  APPROVED 1

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