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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer4February 15, 1985010api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer4June 18, 1981000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer4June 18, 1981010api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler3September 20, 1985000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer3March 12, 2008000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer2June 14, 2011010api.fda.gov
Douglas Medical Products, IncMundelein, IL, United StatesComplaint file establishment, Specification developer2November 10, 1993000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesManufacturer2April 2, 2003030api.fda.gov
Allied Pharmacy Products, Inc.Delray Beach, FL, United StatesSpecification developer1February 24, 1998000api.fda.gov
Baxter Healthcare of Puerto Rico LLCAibonito, PR, United StatesManufacturer1June 14, 2011000api.fda.gov
CGR Minnesota LLCInver Grove Heights, MN, United StatesContract manufacturer, Manufacturer1February 24, 1998000api.fda.gov
Cardinal HealthChicopee, MA, United StatesManufacturer, Repackager or relabeler1September 16, 1981000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1September 16, 1981000api.fda.gov
Gilero, IncPittsboro, NC, United StatesComplaint file establishment, Manufacturer1May 6, 2021000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Repackager or relabeler1October 1, 1979000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesSpecification developer1October 1, 1979000api.fda.gov
Intl. Medical IndustriesPompano Beach, FL, United StatesManufacturer1April 30, 2019000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer1November 2, 1981000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1November 2, 1981000api.fda.gov
Preferred Medical Products, LLCCopperhill, TN, United StatesManufacturer1March 14, 1989000api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer1April 24, 1991000api.fda.gov
Vygon MFGDover, NH, United StatesSpecification developer1December 21, 2004000api.fda.gov
B. Braun Us Pharmaceutical Manufacturing LLCIrvine, CA, United StatesContract manufacturer0010api.fda.gov
Ironwood Industries, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.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.