Product code PQH— General Hospital

“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.”

FDA has cleared 6 devices under product code PQH between 2014 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20202 clearances
• 20181 clearance
• 20161 clearance
• 20141 clearance

• Bayer Medical Care, Inc.2 clearances
• Ulrich GmbH & Co. KG1 clearance
• Liebel-Flarsheim Company, LLC1 clearance
• Bracco Injeneering S.A.1 clearance
• Bayer U.S., LLC1 clearance

• K253688 — MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.·2026-06-12
• K193010 — Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC·2020-11-18
• K200280 — MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.·2020-07-30
• K173913 — MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC·2018-05-04
• K161723 — ulrich Transfer SetUlrich GmbH & Co. KG·2016-12-21
• K133147 — BRACCO INJEENERING TRANSFER SETBracco Injeneering S.A.·2014-06-20