Hyperthermia Pump, 120v
The Belmont Hyperthermia Pump raises the temperature of the thoracic or peritoneal cavity by circulating warmed sterile solution through it. The physician selects the treatment protocol and…
The Belmont Hyperthermia Pump raises the temperature of the thoracic or peritoneal cavity by circulating warmed sterile solution through it. The physician selects the treatment protocol and target temperature. The system combines pumping and fluid warming for continuous lavage of the cavity.
Microprocessor controls regulate fluid delivery and warming. The system monitors fluid and patient temperatures, line pressure and air in the fluid path. Its touchscreen displays flow rate, total fluid pumped, temperatures, pressure and status information so the operator can follow treatment.
Backup Operation
An internal battery supports transport while pumping and safety monitoring continue. Fluid warming is disabled during battery operation. A separate hardware override protects against unsafe operation if the computer fails.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Belmont Instrument Corp., United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| 510(k) | K152208 |
| Record published | 2016-09-23 |
| Record revised | 2023-11-08 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 902-00001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pedigo Products, Inc. | Pedigo Products, Inc. | 207 |
| Amsco | Steris Corporation | 38 |
| Level 1 | ICU Medical, Inc | 26 |
| Skytron warming cabinet | Skytron, LLC | 24 |
| ThermaCor 1200 Infusion System | Smisson-Cartledge Biomedical LLC | 11 |
| Astoflo® Plus ECO | Stihler Electronic Gmbh | 10 |
| enFlow | Carefusion | 8 |
| Fluido® AirGuard System | The Surgical Company International B.V. | 7 |
| Smithworks Medical, Inc. | Smithworks, Inc. | 5 |
| Warming Cabinet Single Compartment Counter-Top Model (Glass Door) | Imperial Surgical Ltd. | 4 |
| Hang&Go PAC | Rand SPA | 4 |
| enFlow™ | Airlife, Inc. | 4 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152208 | 2015-09-02 |
| K131519 | 2013-11-06 |
| K090089 | 2009-02-12 |
| K070654 | 2007-06-08 |
| K032778 | 2003-09-22 |
| K032674 | 2003-09-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Belmont Medical Technologies | 510(k) number | 2025-03-31 | Class II | Process design | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | 158 sets |
| Belmont Medical Technologies | 510(k) number | 2025-03-31 | Class II | Process design | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | 208 sets |
| Belmont Medical Technologies | 510(k) number | 2025-03-31 | Class II | Process design | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | 136 sets |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.