LF

GUDID 20746190004254

Dual CT Syringe with Y-Tubing (60”/1500 mm) and Filling Spikes; for use with OptiVantage

Liebel-Flarsheim Company LLC

Angiography kit

Primary Device ID	20746190004254
NIH Device Record Key	d5868d79-6a13-4ab0-859c-6a3df65233bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	LF
Version Model Number	844022P
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal
Total Volume	200 Milliliter
Pressure	400 Pound per Square Inch
Pressure	2758 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10746190004257 [Primary]
GS1	20746190004254 [Package] Contains: 10746190004257 Package: Case [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042744

FDA Product Code

DXT	Injector And Syringe, Angiographic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-08
Device Publish Date	2021-01-29

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