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CS MEDICAL LLC

Matched from indexed company URL: Cs Medical, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056983293005698329CS MEDICAL LLC1N2026-01-012179 E Lyon Station Rd Creedmoor NC US 27522

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
B205CSTD121TD-12® - PAA High-Level Disinfectant9192559472kendallashe@csmedicalllc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
666062015303042K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorPSW2023-11-21
666061981429943K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorPSW2023-06-07
666061606925070K192445QwikCheck Chemical IndicatorsJOJ2020-04-02
666061516257723K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantPSW2020-04-01
666061844060315K182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level DisinfectantsPSW2019-04-12
666061192142590K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level DisinfectantPSW2016-11-03
666062055810546K141731NEPHROS DSU-H, NEPHROS SSU-HNHV2014-10-24
666061889377735K051305CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5PSW2005-08-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSW62023-11-21
JOJ12020-04-02
NHV12014-10-24

PMN#

GUDID#

Ethos® - The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

CS MEDICAL, LLC

2023-07-31