Data / Medical devices / Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer / United States
FDA-registered makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (product code BZE). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Product code
- BZE
- Country
- United States
Makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 8 | September 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 3 | March 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 2 | November 14, 2014 | 0 | 0 | 0 | api.fda.gov |
| Sunset Healthcare Solutions Central Warehouse | Elgin, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | January 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Exceleron Medical, LLC | Saint Paul, MN, United States | Manufacturer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 1 | June 1, 2011 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | August 2, 2018 | 0 | 1 | 1 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 1 | June 10, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Medical, Inc. | Reno, NV, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics, Inc. | New Kensington, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.