Data / Medical devices / Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact (QEH): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact (product code QEH, Class 2, 21 CFR 880.5860). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 13, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEH
- Device class
- 2
- Regulation
- 880.5860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| Italy | 1 |
| China | 1 |
| Switzerland | 1 |
Makers of Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
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 |
|---|---|---|---|---|---|---|---|---|
| Artiglass SRL | Due Carrare Padova, Italy | Manufacturer | 1 | May 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Exporter to the US, Specification developer | 1 | July 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | September 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson And Company | Columbus, NE, United States | Manufacturer | 1 | September 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Becton, DIckinson and Company | Canaan, CT, United States | Manufacturer | 1 | September 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Intl. Medical Industries | Pompano Beach, FL, United States | Manufacturer | 1 | December 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Manufacturer | 1 | December 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Almo-Erzeugnisse Erwin Busch GMBH | BAD AROLSEN Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical AG | ESCHOLZMATT Luzern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 13, 2024. 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.