LF

GUDID 10746190004073

Angiomat Illumena Contrast Delivery System, Refurbished

Liebel-Flarsheim Company LLC

Angiography contrast medium injection system, line-powered, stationary

• Primary Device ID: 10746190004073
• NIH Device Record Key: 1e20db85-61d6-497d-860f-06421ae82528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LF
• Version Model Number: DS900006
• Company DUNS: 080186051
• Company Name: Liebel-Flarsheim Company LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10746190004073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963071

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-02
• Device Publish Date: 2016-09-09

On-Brand Devices [LF]

• 10746190002093: Tubing with Male Luer Adapter (High Pressure)
• 20746190002083: Tubing with Male Luer Adapter (High Pressure)
• 30746190002059: Tubing with Male Luer Adapter (Low Pressure)
• 10746190002871: OptiStar Elite MR Contrast Delivery System
• 10746190002475: Direct Digital Urology Imaging System, 80 kW
• 10746190002468: Direct Digital Urology Imaging System, 64kW
• 10746190002451: Hydra Vision Urology System, 80 kW
• 10746190002444: Hydra Vision Urology System, 64kW
• 10746190002017: Angio / CT Syringe with Handi-Fil Straw; fits injectors: OptiStat and Angiomat 6000
• 20746190004278: Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena
• 10746190004325: OptiOne Single-Head CT Contrast Delivery System
• 10746190004318: OptiOne Single-Head Contrast Delivery System
• 10746190004967: Illumena, Pedestal Assembly (Accessory)
• 10746190004950: Illumena, Pedestal Assembly (Accessory)
• 10746190004820: OptiVantage/OptiOne, Remote Stand (Accessory)
• 10746190004776: OptiStar Elite, Fixed Height Stand Assembly (Accessory)
• 10746190004707: Illumena, Remote Stand (Accessory)
• 20746190002397: Drain Bag - use with Hydra Vision or Direct Digital Urology Systems
• 20746190002380: Drain Bag used with Hydra Vision or Direct Digital Urology Systems
• 10746190005070: Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
• 10746190005032: Illumena Neo Contrast Delivery System, Table Mount (Accessory)
• 10746190005001: Illumena Neo Contrast Delivery System, U.S. Table Mount Injector Assy (USA; Accessory)
• 10746190004998: Illumena Neo Contrast Delivery System, Fixed Powerhead Table Mount (Accessory)
• 10746190004943: Illumena Neo Contrast Delivery System, Powerpack Rackmount (Accessory)
• 10746190004936: Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
• 10746190004929: Illumena Neo Contrast Delivery System, Electronic Pack Wall Mount (Accessory)
• 10746190004912: Illumena Neo Contrast Delivery System, Rackmount Powerpack Panel (Accessory)
• 10746190004882: Angiomat Illumena Syringe Heater (Accessory)
• 10746190004875: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004868: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004851: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004844: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004837: Angiomat Illumena Foot Switch, Remote Start (Accessory)
• 10746190004813: OptiBolus, Bolus Shaping Software, International (Accessory)
• 10746190004806: OptiBolus, Bolus Shaping Software, Domestic (Accessory)
• 10746190004752: Hand Button Start Switch (Accessory)
• 10746190004745: Hand Button Start Switch (Accessory)
• 10746190004714: Heater Blanket (Accessory)
• 10746190004363: OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface
• 10746190004356: OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface
• 10746190004349: OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface
• 10746190004332: OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface
• 10746190004110: OptiStar LE MR Contrast Delivery System, Demo Loan
• 10746190004080: Angiomat Illumena Contrast Delivery System, Demo Loan
• 10746190004073: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004066: Angiomat Illumena Contrast Delivery System, Demo Loan
• 10746190004059: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004042: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004035: OptiVantage Dual-Head CT Contrast Delivery System, Demo Loan
• 10746190004028: OptiVantage Dual-Head CT Contrast Delivery System, Refurbished