Iodinated Contrast Media Transfer Tubing Set
The Iodinated Contrast Media Transfer Tubing Set is a medical device intended to transfer iodinated contrast media from imaging bulk package containers to multiple sterile single-use syringes under controlled ambient filling conditions such as in a CT suite. It is classified as FDA Class 2 under 21 CFR 880.5440 in the General Hospital specialty, requiring 510(k) clearance. The device enables efficient, controlled filling of syringes for radiology procedures. Product code PQH; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQH
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Jun 12, 2026 | Substantially Equivalent | Bayer Medical Care, Inc. |
| K193010 | Liebel-Flarsheim IBP Transfer Set | Nov 18, 2020 | Substantially Equivalent | Liebel-Flarsheim Company, LLC |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Jul 30, 2020 | Substantially Equivalent | Bayer Medical Care, Inc. |
| K173913 | MEDRAD® Imaging Bulk Package Transfer Set | May 04, 2018 | Substantially Equivalent | Bayer U.S., LLC |
| K161723 | ulrich Transfer Set | Dec 21, 2016 | Substantially Equivalent | Ulrich GmbH & Co. KG |
| K133147 | BRACCO INJEENERING TRANSFER SET | Jun 20, 2014 | Substantially Equivalent | Bracco Injeneering S.A. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.