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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, long term support greater than 6 hours
Definition The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
Product CodeQWF
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

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