Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1518293

FEI Number

1518293

Entity Name

Liebel-Flarsheim Company LLC

City/State/Country

Cincinnati, OH, US

Establishment Address

2111 EAST GALBRAITH RD., Cincinnati, OH 45237, US

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

N/A

PMA Number

N/A

All Registered Proprietary Names

L-F Coiled Extension Tubing Angiomat Illumena OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System OptiStar MR Injector System Qitexio 4-Way Stopcock OptiVantage DH Power Injection System OptiVantage DH Injector System with Enhanced Communication OptiStar Elite Injection System Remote Stand

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-11-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-11-13
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2016-01-15
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-11-13
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-04-30
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-11-13
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2015-11-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-11-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2016-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3012261967	MEDEX	SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1518293. Last updated year: 2026. Please use registration number 1518293 when referencing this establishment in official correspondence.