Device class
Class II
Regulation 880.5440
Total clearances
3
2020-07-30 → 2026-06-12
Definition
What is Iodinated Contrast Media Transfer Tubing Set
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.
Classification details
Medical specialty
General Hospital
Regulation number
880.5440
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