FDA.reportPublic FDA data

MEDEX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30122619673012261967MEDEX1N2026-01-01240 ALLEE JACQUES MONOD SAINT-PRIEST Auvergne-Rhone-Alpes FR 69800
30122619673012261967MEDEX1N2020-04-25240 ALLEE JACQUES MONOD SAINT-PRIEST Rhone-Alpes FR 69800

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
13700550400971Qitexio Luer Lock Syringe 20mL - QIT0131-877-729-6679customer.service-us@guerbet.com
23700550400763Qitexio 4-Way Stopcock - Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.1-877-729-6679customer.service-us@guerbet.com
23700550400978Qitexio Luer Lock Syringe 20mL - QIT0131-877-729-6679customer.service-us@guerbet.com
33700550400760Qitexio 4-Way Stopcock - Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.1-877-729-6679customer.service-us@guerbet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2898361145182381K242255Qitexio® 4-Way Stopcock (QIT014)FMG2025-04-29
2898361462712705K203738QitexioFMF2022-03-14
1996741358840152
1996741572495532

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMG12025-04-29
FMF12022-03-14

PMN#

GUDID#