Liebel-Flarsheim OptiStat Contrast Delivery System and Accessories

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Transmedic Pte Ltd

Class:

Class C medical device

Manufactured by:

Liebel Flarsheim Company LLC

Therapeutic area:

Radiology / Imaging

Therapeutic indications:

The Liebel-Flarsheim OptiStat Injector is designed to inject a radiopaque contrast media into a patient’s vascular system, which enhances diagnostic images obtained with X-ray procedures. Each injection is accomplished with a motor driven syringe mechanism with microprocessor control of the flow rate, volume and timing. Contraindications for the use of this device are determined by the prescribing physician at the time of use and upon the contrast media package inserts.

Product summary:

Device System Info:[Sterile Medical Device], Syringes and Tubings sterilized by ETO; Models: Optistat™ - Handheld CT Contrast Delivery System - Domestic With Console - 810000, Optistat™ - Handheld CT Contrast Delivery System - Domestic Without Console - 810001, Optistat™ - Handheld CT Contrast Delivery System - Domestic With Console - 810005, Optistat™ - Handheld CT Contrast Delivery System - Domestic Without Console - 810006, Optistat™ - Handheld CT Contrast Delivery System Console - 810025, UNIVERSAL INTERFACE BOARD PCB - 800889-1, FIL ASSY CONSOLE - 810025, CABLE ASSY CONSOLE 7 FT - 810140, CT POWERHEAD - 810150, KIT REMOTE STAND MNT OPTISTAT - 810175, IV POLE POWER HEAD MOUNT - 810192, KEYPAD-POWERHEAD - 810335, OPTISTAT INTERFACE KIT - 810615, KIT INTRFAC CT9000ADV-OPTISTAT - 810620, OPTISTAT MOUNTING KIT - 810706, Optistat™ - Interface Kit - 810720, INTRFACE KT OPTISTAT - 810721, Handifil Disposable Filler Tube - 302050, SYR 200ML W/H-FIL-MEDRAD BX50 - 601350, SYR 150ML W/H-FIL-MEDRAD BX50 - 601360, CTMPAK 200ML H-FIL-MEDRAD BX50 - 601370, TRIPACK 200ML SYR-BX50 - 601590, 200ML SYRINGE W/HANDI-FIL - 800096, KIT SYRINGE ADAPTER ASSY - 810430, 150ML SYRINGE W/ HANDIFIL X50 - 900064, 200ML SYRINGE W/ HANDIFIL X50 - 900073, COILED TUBING - 60IN COILED LOW PRESSURE TUBING FOR CT [100 UNITS PER CASE] - 601195, Y ADAPTER TUBING W/DUAL CHECK - 810555, ASSY WALL HANGER - 810160, CLAMP IV POLE - 810910, MANUAL PACKAGE - 810832

Authorization date:

2006-12-05