Chrysalis Intelligence · Product Codes · PQH

PQH · Iodinated Contrast Media Transfer Tubing Set

General Hospital · 3 clearances · 2 unique sponsors

Device class
Class II
Regulation 880.5440
Total clearances
3
2020-07-30 → 2026-06-12
Last 12 months
1
Unique sponsors
2
Definition

What is Iodinated Contrast Media Transfer Tubing Set

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.
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5440
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Bayer Medical Care, Inc. 2 1 2026-06-12
Liebel-Flarsheim Company, LLC 1 0 2020-11-18
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-12 K253688 Bayer Medical Care, Inc. MEDRAD® Imaging Bulk Package Transfer Spike
2020-11-18 K193010 Liebel-Flarsheim Company, LLC Liebel-Flarsheim IBP Transfer Set
2020-07-30 K200280 Bayer Medical Care, Inc. MEDRAD Imaging Bulk Package Transfer Spike