FDA.reportPublic FDA data

LF

Primary DI
10746190004356
Brand
LF
Company
Liebel-Flarsheim Company LLC
Model
849002
Device description
OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface
Published
2020-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZQInjector, Contrast Medium, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZQInjector, Contrast Medium, AutomaticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063503000OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATIONMallinckrodt Inc., Liebel-Flarsheim Business2007-04-27IZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10746190004356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1074619000435610746190004356

GMDN Terms#

Term, Definition table
TermDefinition
CT contrast medium injection system, line-powered, stationaryAn assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080186051
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10746190002222LF8105512018-12-07
10746190002260LF8440122016-09-09
10746190002116LF8000992016-09-09
10746190002376LF9001052016-09-09
10746190002208LF8018002016-09-09
10746190002314LF8440222016-09-09
10746190002109LF8000962016-09-09
10746190002307LF8440212016-09-09
10746190002321LF8440232016-09-09
10746190002000LF3020502016-09-16
10746190005049LF9898 012 200462024-12-30
10746190002239LF8105552018-12-07
10746190002024LF6002692016-09-09
10746190002048LF6011952016-09-09
10746190002086LF6012802020-03-03
10746190002185LF8011062016-09-09
10746190002192LF8011072016-09-09
10746190002215LF8018012016-09-09
10746190002246LF8440102016-09-09
10746190002253LF8440112016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDIZQ2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-12-10
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.IZQ2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.IZQ2025-12-10
10841716103442CT Exprès Bottle Spike AACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
10841716103466CT Exprès Day Set III HPACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
04052536230495ulrichINJECT CT motionUlrich GmbH & Co. KGIZQ2025-12-02
10841716103480CT Exprès Patient SetACIST MEDICAL SYSTEMS, INC.IZQ2025-08-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
49345390003095MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDIZQ2025-03-28
17630039302051Remote ControlBracco Injeneering SAIZQ2024-05-29
04052536166459ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166473ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175130ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175222ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203642ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203673ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203703ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203833ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203857ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166466ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166480ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175147ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175239ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203659ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203697ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203710ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29