Data / Medical devices / Warmer, Blood, Non-Electromagnetic Radiation
Warmer, Blood, Non-Electromagnetic Radiation (BSB): 19 FDA-registered makers in 6 countries
19 establishments in 6 countries are registered with the FDA to make Warmer, Blood, Non-Electromagnetic Radiation (product code BSB, Class 2, 21 CFR 864.9205). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on November 16, 2011, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- BSB
- Device class
- 2
- Regulation
- 864.9205
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 5 |
| Denmark | 3 |
| Germany | 1 |
| Poland | 1 |
| Israel | 1 |
Makers of Warmer, Blood, Non-Electromagnetic Radiation
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 |
|---|---|---|---|---|---|---|---|---|
| Belmont Medical Technologies | Billerica, MA, United States | Manufacturer | 2 | November 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Estill Medical Technologies, Inc. | Dallas, TX, United States | Specification developer | 2 | July 26, 2001 | 0 | 1 | 0 | api.fda.gov |
| Stihler Electronic GMBH | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Manufacturer | 2 | September 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Eden Prairie, MN, United States | Manufacturer, Repackager or relabeler | 1 | April 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| A/S Kurt Hansen | Svendborg Syddanmark, Denmark | 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 | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Contract manufacturer, Contract sterilizer | 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 | |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | 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 | |
| Mequ A/S | Copenhagen Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | 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 | |
| Quality In Flow Ltd. | PETAH TIKVA Central, Israel | Manufacturer | 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 |
Updated November 16, 2011. 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.