FDA.reportPublic FDA data

THERMASOLUTIONS LLC.

Matched from indexed company URL: THERMASOLUTIONS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056997843005699784THERMASOLUTIONS LLC.1N2026-01-011889 Buerkle Rd White Bear Lake MN US 55110
30069862573006986257ThermaSolutions Europe B.V.1N2026-01-01Takkebijsters 41 Breda Noord-Brabant NL 4817

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851450007114ThermaSolutions - Temperature probe-single TMP-1304+1-877-952-6100info@thermasolutions.com
00851450007275ThermoChem - The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir.1.877.952.6100info@thermasolutions.com
00851450007282ThermoChem - The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir.651-209-3900info@thermasolutions.com
00851450007299HurriChem Device Kit - HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.651-209-3900info@thermasolutions.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
661871900037050K993330THERMOCHEM-HT SYSTEMMLW1999-12-30
2201501900037050K993330THERMOCHEM-HT SYSTEMMLW1999-12-30
661871466348027K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)MLW2025-05-05
2201501466348027K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)MLW2025-05-05
661871372520900K222575HurriChem Device KitGCJ2022-12-06
661871284381970K131583THERMOCHEM HT-2000MLW2013-10-03
2201501284381970K131583THERMOCHEM HT-2000MLW2013-10-03
661871816742111K101244SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBEFLL2010-11-18
661871650881127
2201501650881127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLW62025-05-05
GCJ12022-12-06
FLL12010-11-18

PMN#

GUDID#