LF

GUDID 10746190005001

Illumena Neo Contrast Delivery System, U.S. Table Mount Injector Assy (USA; Accessory)

LIEBEL-FLARSHEIM COMPANY LLC

Angiography contrast medium injection system, line-powered, stationary Angiography contrast medium injection system, line-powered, stationary Angiography contrast medium injection system, line-powered, stationary Angiography contrast medium injection system, line-powered, stationary
Primary Device ID10746190005001
NIH Device Record Key4f36e2bf-008c-4364-9294-4f151f298c70
Commercial Distribution StatusIn Commercial Distribution
Brand NameLF
Version Model Number600151
Company DUNS152760567
Company NameLIEBEL-FLARSHEIM COMPANY LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110746190005001 [Primary]
GS110746190005001 [Primary]
GS110746190005001 [Primary]
GS110746190005001 [Primary]

FDA Product Code

FOXStand, Infusion
FOXStand, Infusion
FOXStand, Infusion
FOXStand, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [LF]

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10746190002475Direct Digital Urology Imaging System, 80 kW
10746190002468Direct Digital Urology Imaging System, 64kW
10746190002451Hydra Vision Urology System, 80 kW
10746190002444Hydra Vision Urology System, 64kW
10746190002017Angio / CT Syringe with Handi-Fil Straw; fits injectors: OptiStat and Angiomat 6000
20746190004278Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena
10746190004325OptiOne Single-Head CT Contrast Delivery System
10746190004318OptiOne Single-Head Contrast Delivery System
10746190004967Illumena, Pedestal Assembly (Accessory)
10746190004950Illumena, Pedestal Assembly (Accessory)
10746190004820OptiVantage/OptiOne, Remote Stand (Accessory)
10746190004776OptiStar Elite, Fixed Height Stand Assembly (Accessory)
10746190004707Illumena, Remote Stand (Accessory)
20746190002397Drain Bag - use with Hydra Vision or Direct Digital Urology Systems
20746190002380Drain Bag used with Hydra Vision or Direct Digital Urology Systems
10746190005070Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
10746190005032Illumena Neo Contrast Delivery System, Table Mount (Accessory)
10746190005001Illumena Neo Contrast Delivery System, U.S. Table Mount Injector Assy (USA; Accessory)
10746190004998Illumena Neo Contrast Delivery System, Fixed Powerhead Table Mount (Accessory)
10746190004943Illumena Neo Contrast Delivery System, Powerpack Rackmount (Accessory)
10746190004936Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
10746190004929Illumena Neo Contrast Delivery System, Electronic Pack Wall Mount (Accessory)
10746190004912Illumena Neo Contrast Delivery System, Rackmount Powerpack Panel (Accessory)

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