Data / Medical devices / Pump, Infusion, Pca
Pump, Infusion, Pca (MEA): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Pump, Infusion, Pca (product code MEA, Class 2, 21 CFR 880.5725). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on August 29, 2017, and lists 27 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- MEA
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Mexico | 4 |
| Germany | 2 |
| Costa Rica | 1 |
Makers of Pump, Infusion, Pca
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 |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 7 | April 8, 2016 | 0 | 5 | 0 | api.fda.gov |
| ICU Medical Costa Rica Ltd. | La Aurora de Heredia, Costa Rica | Manufacturer | 3 | August 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 2 | August 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Avent S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 2 | August 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Diego, CA, United States | Specification developer | 2 | April 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Complaint file establishment, Exporter to the US, Specification developer | 1 | November 4, 2009 | 0 | 0 | 0 | api.fda.gov |
| CareFusion 303, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | December 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| CareFusion 303, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | December 10, 2004 | 0 | 1 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | February 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Avitum AG | MELSUNGEN Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sistemas Medicos Alaris S.A de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 29, 2017. 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.