Data / Medical devices / Warmer, Thermal, Infusion Fluid
Warmer, Thermal, Infusion Fluid (LGZ): 46 FDA-registered makers in 13 countries
46 establishments in 13 countries are registered with the FDA to make Warmer, Thermal, Infusion Fluid (product code LGZ, Class 2, 21 CFR 880.5725). 23 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 76 510(k) clearances under this code, the latest on September 18, 2026, and lists 19 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- LGZ
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 22 |
| Netherlands | 6 |
| Mexico | 5 |
| Denmark | 3 |
| Germany | 2 |
| Israel | 1 |
| Italy | 1 |
| Austria | 1 |
| Canada | 1 |
| Belgium | 1 |
| Nicaragua | 1 |
| China | 1 |
| Malaysia | 1 |
Makers of Warmer, Thermal, Infusion Fluid
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Solutions, Inc. | Chantilly, VA, United States | Complaint file establishment, Specification developer | 7 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Quality In Flow Ltd. | PETAH TIKVA Central, Israel | Manufacturer | 4 | December 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 3 | June 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 3 | June 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Montgomery, AL, United States | Manufacturer | 3 | July 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Belmont Medical Technologies | Billerica, MA, United States | Manufacturer | 2 | September 2, 2015 | 0 | 2 | 0 | api.fda.gov |
| Mequ A/S | Copenhagen Hovedstaden, Denmark | Specification developer | 2 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Pedigo Products, Inc. | Vancouver, WA, United States | Manufacturer | 2 | December 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| RAND S.p.A. | MEDOLLA Modena, Italy | Manufacturer | 2 | December 28, 2016 | 0 | 1 | 0 | api.fda.gov |
| Smisson-Cartledge Biomedical LLC | Macon, GA, United States | Specification developer | 2 | August 12, 2022 | 0 | 1 | 1 | api.fda.gov |
| TSC Life | Almelo Overijssel, Netherlands | Manufacturer | 2 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| The Surgical Company International B.V. | Amsterdam Noord-Holland, Netherlands | Specification developer | 2 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biegler GMBH | MAUERBACH Niederosterreich, Austria | Manufacturer | 1 | July 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Contract manufacturer, Manufacturer | 1 | October 17, 1991 | 0 | 0 | 0 | api.fda.gov |
| Imperial Surgical Ltd. | Lachine Quebec, Canada | Manufacturer | 1 | March 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Mac Medical | Millstadt, IL, United States | Contract manufacturer, Manufacturer | 1 | March 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Manufacturer | 1 | June 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Smithworks, Inc. | Lindale, TX, United States | Manufacturer, Remanufacturer | 1 | December 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | June 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Stihler Electronic GMBH | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Manufacturer | 1 | December 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | June 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Eden Prairie, MN, United States | Manufacturer | 1 | June 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| A/S Kurt Hansen | Svendborg Syddanmark, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aim B.V. | Brunssum Limburg, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avances Cientificos de Mexico | H. Matamoros Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beldico S.A. | Marche-en-Famenne Luxembourg, Belgium | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecm Europe BV | Gemert Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enercon Technologies | Gray, ME, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Estill Medical Technologies, Inc. | Dallas, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garrett Heilbrun Technology Partners, LLC Dba Cobalt Product Solutions | Plano, TX, United States | Contract manufacturer | 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 | |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MFG One, LLC | Chantilly, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul E. Danchell A/S | Jyderup Sjaelland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROVITA Medical GmbH & Co. KG | WERMELSKIRCHEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Asia Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER Communications, Inc. | Flower Mound, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermedx, LLC | Solon, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Group BV | IJzendijke Zeeland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variass Medical Systems BV | Drachten Fryslan, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 18, 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.