Data / Medical devices / Container, I.V. / United States
FDA-registered makers of Container, I.V. in the United States: 25 establishments
25 establishments in the United States are registered with the FDA to make Container, I.V. (product code KPE). 22 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Container, I.V.
- Product code
- KPE
- Country
- United States
Makers of Container, I.V. in the United States
| 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 | 4 | February 15, 1985 | 0 | 1 | 0 | api.fda.gov |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 4 | June 18, 1981 | 0 | 0 | 0 | api.fda.gov |
| Microtek Medical LLC | Northfield, IL, United States | Specification developer | 4 | June 18, 1981 | 0 | 1 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 3 | September 20, 1985 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 3 | March 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 2 | June 14, 2011 | 0 | 1 | 0 | api.fda.gov |
| Douglas Medical Products, Inc | Mundelein, IL, United States | Complaint file establishment, Specification developer | 2 | November 10, 1993 | 0 | 0 | 0 | api.fda.gov |
| The Metrix Company | Dubuque, IA, United States | Manufacturer | 2 | April 2, 2003 | 0 | 3 | 0 | api.fda.gov |
| Allied Pharmacy Products, Inc. | Delray Beach, FL, United States | Specification developer | 1 | February 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare of Puerto Rico LLC | Aibonito, PR, United States | Manufacturer | 1 | June 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| CGR Minnesota LLC | Inver Grove Heights, MN, United States | Contract manufacturer, Manufacturer | 1 | February 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Chicopee, MA, United States | Manufacturer, Repackager or relabeler | 1 | September 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | September 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Gilero, Inc | Pittsboro, NC, United States | Complaint file establishment, Manufacturer | 1 | May 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Repackager or relabeler | 1 | October 1, 1979 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 1 | October 1, 1979 | 0 | 0 | 0 | api.fda.gov |
| Intl. Medical Industries | Pompano Beach, FL, United States | Manufacturer | 1 | April 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer | 1 | November 2, 1981 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 1 | November 2, 1981 | 0 | 0 | 0 | api.fda.gov |
| Preferred Medical Products, LLC | Copperhill, TN, United States | Manufacturer | 1 | March 14, 1989 | 0 | 0 | 0 | api.fda.gov |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 1 | April 24, 1991 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Specification developer | 1 | December 21, 2004 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Us Pharmaceutical Manufacturing LLC | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ironwood Industries, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.