Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012261967

FEI Number

3012261967

Entity Name

MEDEX

City/State/Country

SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Establishment Address

240 ALLEE JACQUES MONOD, SAINT-PRIEST Auvergne-Rhone-Alpes 69800, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guerbet LLC / Liebel-Flarsheim Company LLC (Owner Number: 10050387)

Owner / Operator Contact Address

214 Carnegie Center, Suite 300, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203738

PMA Number

N/A

All Registered Proprietary Names

Qitexio 4-Way Stopcock Qitexio Luer Lock Syringes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-04-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

Alpa Jain Business: Guerbet LLC Email: alpa.jain@guerbet.com Phone: (609) 4806340

Related Public Records

Same Entity

Guerbet LLC / Liebel-Flarsheim Company LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1518293	Liebel-Flarsheim Company LLC	Cincinnati, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012261967. Last updated year: 2026. Please use registration number 3012261967 when referencing this establishment in official correspondence.