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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Transfer with swabbable valve to directly connect to single use sterile syringes.
Technical Method Transfer set may include a swabbable one way valve to aid in filling of single use sterile syringes and prevention of microbial ingress.
Target Area Device does not act on any part of the body.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePQH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible