Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → PQH — Iodinated Contrast Media Transfer Tubing Set

# PQH · Iodinated Contrast Media Transfer Tubing Set

_General Hospital · 21 CFR 880.5440 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH

## Overview

- **Product Code:** PQH
- **Device Name:** Iodinated Contrast Media Transfer Tubing Set
- **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

## Classification Rationale

Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

## Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K193010](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH/K193010.md) | Liebel-Flarsheim IBP Transfer Set | Liebel-Flarsheim Company, LLC | Nov 18, 2020 | SESE |
| [K200280](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH/K200280.md) | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | Jul 30, 2020 | SESE |
| [K173913](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH/K173913.md) | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | May 4, 2018 | SESE |
| [K161723](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH/K161723.md) | ulrich Transfer Set | Ulrich GmbH & Co. KG | Dec 21, 2016 | SESE |
| [K133147](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH/K133147.md) | BRACCO INJEENERING TRANSFER SET | Bracco Injeneering S.A. | Jun 20, 2014 | SESE |

## Top Applicants

- Bayer Medical Care, Inc. — 1 clearance
- Bayer U.S., LLC — 1 clearance
- Bracco Injeneering S.A. — 1 clearance
- Liebel-Flarsheim Company, LLC — 1 clearance
- Ulrich GmbH & Co. KG — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PQH)

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