Data / Medical devices / Accessories, Pump, Infusion
Accessories, Pump, Infusion (MRZ): 24 FDA-registered makers in 9 countries
24 establishments in 9 countries are registered with the FDA to make Accessories, Pump, Infusion (product code MRZ, Class 2, 21 CFR 880.5725). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on June 15, 2023, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRZ
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 4 |
| Costa Rica | 1 |
| Mexico | 1 |
| South Korea | 1 |
| Italy | 1 |
| Israel | 1 |
| France | 1 |
| Turkey | 1 |
Makers of Accessories, Pump, Infusion
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 | 4 | August 25, 2017 | 0 | 2 | 0 | api.fda.gov |
| American I.V. Products, Inc. | Harmans, MD, United States | Manufacturer | 2 | December 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Costa Rica Ltd. | La Aurora de Heredia, Costa Rica | Manufacturer | 2 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer | 2 | October 17, 2007 | 0 | 0 | 0 | api.fda.gov |
| Welldoc | Columbia, MD, United States | Manufacturer | 2 | April 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | August 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Exporter to the US, Specification developer | 1 | March 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Border Assembly S de RL de CV | TIJUANA Baja California, Mexico | Complaint file establishment, Manufacturer | 1 | June 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Carelife (usa) Inc. | Alpharetta, GA, United States | Specification developer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Elite Biomedical Solutions LLC | Cincinnati, OH, United States | Manufacturer | 1 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ivwatch, LLC | Newport News, VA, United States | Manufacturer | 1 | February 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Roche Diabetes Care GmbH | Mannheim Baden-Wurttemberg, Germany | Manufacturer | 1 | May 15, 2008 | 0 | 0 | 0 | api.fda.gov |
| Sooil Development Co., Ltd. | Yongin-si Gyeonggi, South Korea | Exporter to the US, Manufacturer | 1 | September 4, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CANE' S.p.A. | RIVOLI-CASCINE VICA Torino, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eitan Medical LTD | Netanya Central, Israel | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Vial S.A.S. | Brezins Isere, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MIPM Mammendorfer Institut fur Physik und Medizin GmbH | MAMMENDORF/MUNICH Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MOMENI ENGINEERING dba Essex Industries | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Neenah, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 15, 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.