FDA.reportPublic FDA data

THERMEDX, LLC

Matched from indexed company URL: THERMEDX LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074958793007495879THERMEDX, LLC1N2026-01-0131200 Solon Road Unit 1 Solon OH US 44139
30074958793007495879THERMEDX, LLC1N2020-04-2531200 Solon Road Unit 1 Solon OH US 44139

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
00860936000365Urology Set - LL00061.888.542.9277aturner@thermedx.com
20860936000369Urology Set - LL00061.888.542.9277aturner@thermedx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3049901085818389K172048FluidSmartHIG2017-09-05
996721858004607K172048FluidSmartHIG2017-09-05
996721323716833K133799THERMEDX FLUID MANAGMENT SYSTEMHIG2014-06-20
3049901390557125K133799THERMEDX FLUID MANAGMENT SYSTEMHIG2014-06-20
996721090713768K091939THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000HIG2010-07-23
3049901508202106K091939THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000HIG2010-07-23
3049901734360849

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIG62017-09-05

PMN#

GUDID#