FDA.reportPublic FDA data

LF

Primary DI
10746190004714
Brand
LF
Company
Liebel-Flarsheim Company LLC
Model
800114
Device description
Heater Blanket (Accessory)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10746190004714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1074619000471410746190004714

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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