Data / Medical devices / Administrations Sets With Neuraxial Connectors
Administrations Sets With Neuraxial Connectors (PWH): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Administrations Sets With Neuraxial Connectors (product code PWH, Class 2, 21 CFR 880.5440). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 21, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PWH
- Device class
- 2
- Regulation
- 880.5440
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 2 |
| Dominican Republic | 1 |
Makers of Administrations Sets With Neuraxial Connectors
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 |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 1 | November 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare, S.A. | Haina San Cristobal, Dominican Republic | Manufacturer | 1 | November 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | July 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | July 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | July 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 21, 2023. 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.