FDA.reportPublic FDA data

MEDEX

Matched from indexed company URL: Medex

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035892793003589279MEDEXEL CO., LTD.1N2026-01-01252, GeumgwangOsan-Ro, Geumgwang-myeon Anseong-si Gyeonggi KR 17535
30122619673012261967MEDEX1N2026-01-01240 ALLEE JACQUES MONOD SAINT-PRIEST Auvergne-Rhone-Alpes FR 69800
30108677803010867780MEDEX CO., LTD1N2020-04-25162, Yulsaengjungang-ro, Daegot-myeon Gimpo Gyeonggido KR 10039
30122619673012261967MEDEX1N2020-04-25240 ALLEE JACQUES MONOD SAINT-PRIEST Rhone-Alpes FR 69800
30132251543013225154MEDEX SURGICAL LLP1Y2020-04-252245 Keller Springs Suite 140 Carrollton TX US 75006

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
202701996304241K895768EXEL SAFELET CATHETERFOZ1990-02-16
202701509916156K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESFMF1986-04-23
202701807470015K861152EXEL VACUUM BLOOD COLLECTING SYSTEMFMI1986-05-06
2898361145182381K242255Qitexio® 4-Way Stopcock (QIT014)FMG2025-04-29
2898361462712705K203738QitexioFMF2022-03-14
202701568079385K172095AutokeeperFMI2018-07-24
202701820222419K152410Top Fine Pen NeedleFMI2016-02-02
202701899561015K113186STERILE INSULIN PEN NEEDLEFMI2012-04-12
202701371400239K063466TOP FINEFMI2007-03-02
202701302175662K063348TOP FINE INSULIN SYRINGEFMF2007-03-01
202701844486835K043419P&P SAFETY SYRINGEMEG2005-04-15
202701865677542K011757EXEL COMFORTPOINT INSULIN PEN NEEDLEFMI2002-01-23
202701993583002K011754EXEL SECURETOUCH PTP SYRINGEMEG2003-01-22
1716801039553418
1996741358840152
1996741572495532
202701636387690
202701875381313
202701915378955

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI62018-07-24
FMF42022-03-14
MEG22005-04-15
FMG12025-04-29
FOZ11990-02-16

NDC#

PMN#

53 records. Showing 1-40. Next

Applications#

GUDID#