FDA.reportPublic FDA data

MEDRAD® Centargo CT Injection System

Primary DI
09345390003356
Brand
MEDRAD® Centargo CT Injection System
Company
IMAXEON PTY LTD
Model
CENT-SYS-OCS
Catalog number
CENT-SYS-OCS
Device description
CENTARGO,SYSTEM,INJECTOR,OCS,US (91063586)
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09345390003356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09345390003356093453900033569345390003356

GMDN Terms#

Term, Definition table
TermDefinition
CT contrast medium injection system, line-powered, mobileAn 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 (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity-20 Degrees Celsius60 Degrees Celsius
Handling Environment Humidity5 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 800-633-7231ricustomercomplaints@bayer.com

Regulatory Flags#

DUNS number
740733993
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)CENT-PL-350CENT-PL-3502026-05-06
09345390003530MEDRAD® Centargo Patient LineCENT-PLCENT-PL2025-12-10
49345390003538MEDRAD® Centargo Patient LineCENT-PLCENT-PL2025-12-10
09345390002656MEDRAD® Centargo Patient LineCENT-PLCENT-PL2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeCENT-RSCENT-RS2025-03-28
09345390003097MEDRAD® Centargo Day Set CENT-DSCENT-DS2025-03-28
49345390002654MEDRAD® Centargo Patient LineCENT-PLCENT-PL2025-03-28
49345390002715MEDRAD® Centargo Replacement SpikeCENT-RSCENT-RS2025-03-28
49345390003095MEDRAD® Centargo Day Set CENT-DSCENT-DS2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemCENT-SYS-BATCENT-SYS-BAT2025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065992NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05