FLOWSENS^® LEGAL MENTIONS

FlowSens^® is a medical device intended for use by Healthcare professionals, it is a contrast media and saline solution dual bag injector used in CT-scanner exams.

For complete information about precautions and optimal usage conditions, we recommend consulting the instruction for use supplied with the device or by your local Guerbet representative(s). For use only in countries with applicable health authority registrations

Class IIb/CE
GMED 0459
Manufacturer: Medex
EC Rep: Guerbet
FlowSens^® is trademark of Guerbet. Patent issued.

OPTIVANTAGE_™ LEGAL MENTIONS

Optivantage™ DH Contrast Media Injectors is a medical device intended for use by qualified healthcare professionals, it is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

These medical devices are intended for use by medical imaging and diagnostic healthcare professionals. For complete information about precautions and optimal usage conditions for these medical devices, we recommend consulting the instructions notices/user’s manuals.

Ensure that injection from multi-dose containers and to more than one patient respects the valid rules of good practice and the marketing authorization (MA) of the contrast agent and local regulatory requirements.

Class IIb/CE
TÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet

OptiVantage™ is trademark of Guerbet OptiVantage™, Patency Check^®, Timing Bolus^®, Patents pending and issued patents.

OPTIBOLUS^®

OptiBolus^® may be subject to an additional fee; Can differ from country to country; For more information, please contact your local Guerbet representative.

OptiBolus^® is trademark of Guerbet, Patents pending and issued patents.

OPTIONE^™ LEGAL MENTIONS

The OptiOne™ Single-Head Contrast Media Injector is a class IIb (CE) medical device intended for use by qualified healthcare professionals, is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography (CT) equipmentFor complete information about precautions and optimal usage conditions, we recommend consulting the instruction for use supplied with the device or by your local Guerbet representative(s). For use only in countries with applicable health authority registrations

Class IIb/CE
TÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet

OptiOne™ is trademark of Guerbet, Patents pending and issued patents.

OPTISTAR^™ LEGAL MENTIONS

Optistar™ Elite Contrast Delivery System is a medical device intended for use by qualified healthcare professionals. It is intended to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used in conjunction with Magnetic Resonance (MR) Imaging equipment. For complete information about precautions and optimal usage conditions, we recommend consulting the instruction for use supplied with the device or by your local Guerbet representative(s). For use only in countries with applicable health authority registrations

Class IIb/CE
TÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet

OptiStar™ is trademark of Guerbet

MRI SYRINGE ADAPTER

These accessories are intended for use by medical imaging and diagnostic healthcare professionals.

For complete information about precautions and optimal usage conditions for these accessories, we recommend consulting the instructions notices/user’s manuals.

ILLUMENA^™ LEGAL MENTIONS

Illumena™ Néo Contrast Media Injectors is a medical device intended for use by qualified healthcare professionals, it is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

Class IIb/CE
TÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet

READYBOX^® LEGAL MENTIONS

Ready-Box^® Contrast Warmer is a medical device intended for use by qualified healthcare professionals to warm contrast media to approximately body temperature,

Class IIa/CE
TÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet

CONSUMABLES LEGAL MENTIONS

LF Injector Disposables are a medical devices intended for use by qualified healthcare professionals and designed to be used in the LF contrast injection systems. They contain the contrast and provide the delivery path for the contrast to the patient. The injection systems are designed to inject contrast media into a patient’s vascular system to obtain diagnostic images when used with computed tomography (CT), MR, Angiographic or x-ray equipment.
Class IIa/CE TÜV SÜD 0123 Manufacturer: Liebel-Flarsheim Company LLC. Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.

MANYFILL™ range are medical devices intended for use by qualified healthcare professionals for intravenous administration of CT or/and MRIcontrast media for single or dual syringes injector.
Class IIa/CE GMED 0459 Manufacturer: Medex
Manyfill™ is trademark of Guerbet. Issued patents.

SECUFILL™ range are medical devices intended for use by qualified healthcare professionals. Secufill products are long safety patient lines with double threshold valve. For all CT-scanner or MRI injectors.
Class IIa/CE GMED 0459 Manufacturer: Medex
Secufill™ is trademark of Guerbet. Issued patents.

Pressure Connecting Tubes are medical devices intended for use by qualified healthcare professionals. They are provided with 2 check valves or 1 double-valve.
They are used by connecting with a multi-patient syringe system to inject contrast media and/or saline within the areas of Computed Tomography and Magnetic Resonance Imaging.
Class IIa/CE TÜV SÜD 0123
Manufacturer: Shenzhen Antmed Co., Ltd.

For complete information about precautions and optimal usage conditions, we recommend consulting the instruction for use supplied with these devices or by your local Guerbet representative(s).
For use only in countries with applicable health authority registrations.

I25003419 - March 2025