FDA Registration
Active
🇺🇸 United States
THERMASOLUTIONS LLC.
Reg #: 3005699784
·
FEI: 3005699784
·
Expires 2026
Products
4
Proprietary Names
11
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- THERMASOLUTIONS LLC.
- Registration Number
- 3005699784
- FEI Number
- 3005699784
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1889 Buerkle Rd
- City
- White Bear Lake
- State
- MN
- ZIP
- 55110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240447
Owner / Operator
- Firm Name
- THERMASOLUTIONS LLC.
- Operator Number
- 9082263
- Address
- 1889 Buerkle Road
- City
- White Bear Lake
- State
- MN
- Postal Code
- 55110
- Country
- US
- Correspondent
- Rhea Johny
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Peritoneal Dialysate | MLW | Class 2 | Gastroenterology, Urology | No | 2025-11-24 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-01-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-04-09 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2022-12-27 |
Proprietary Names
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
HurriChem Device Kit
THERMOCHEM HT-1000
Temperature Probe TMP-1308
Temperature Probe TMP-1304
ThermoChem HT-2000
ThermoChem HT-2500
FLW-0111 Long Lasso Tubing
PAK-0112 Inflow and Outflow Tubing Pack
FLW-0010 Lasso Tubing
FLW-0120 Inflow Tubing
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device