Data / Medical devices / Iodinated Contrast Media Transfer Tubing Set
Iodinated Contrast Media Transfer Tubing Set (PQH): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Iodinated Contrast Media Transfer Tubing Set (product code PQH, Class 2, 21 CFR 880.5440). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 12, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PQH
- Device class
- 2
- Regulation
- 880.5440
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 2 |
| Switzerland | 1 |
| Costa Rica | 1 |
Makers of Iodinated Contrast Media Transfer Tubing Set
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bayer Medical Care Inc. | Indianola, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 2 | July 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bracco Injeneering S.A. | LAUSANNE Vaud, Switzerland | Specification developer | 1 | June 20, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical SRL | Barreal de Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerpiece S. De R.L De C.V | Playas de Rosarito Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.) | Washington, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Chester, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| RM Healthcare Products SA de CV | JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.