FDA product code PQH

Iodinated Contrast Media Transfer Tubing Set

General Hospital·Class 2·21 CFR 880.5440
US regulatory classifications
US Product Code (FDA)
PQH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5440
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Iodinated Contrast Media Transfer Tubing Set is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.