# Iodinated Contrast Media Transfer Tubing Set
> **Product code: PQH** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440
## Classification
- **FDA Product Code:** PQH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5440
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PQH)
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