FDA.reportPublic FDA data

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#

GLEOLAN

Medexus Pharma, Inc.

AMINOLEVULINIC ACID HYDROCHLORIDE

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Ixinity

Medexus Pharma, Inc.

coagulation factor IX (recombinant)

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Rasuvo

Medexus Pharma Inc.

methotrexate

Hexatrione

Medexus Pharma, Inc.

triamcinolone hexacetonide

Oxygen

Medex LLC dba Medical Express

Oxygen

PMN#

53 records. Showing 1-40. Next

Applications#

GUDID#

Qitexio 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.

MEDEX

2025-05-09

Qitexio 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.

MEDEX

2025-05-09