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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device iodinated contrast media transfer tubing set
Regulation Description Intravascular administration set.
Definition The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite.
Product CodePQH
Regulation Number 880.5440
Device Class 2

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