FDA.reportPublic FDA data

MEDRAD® Centargo Patient Line

Primary DI
09345390003530
Brand
MEDRAD® Centargo Patient Line
Company
IMAXEON PTY LTD
Model
CENT-PL
Catalog number
CENT-PL
Device description
ASSY,TUBESET,CENTARGO SUDS,US (91855938)
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic
IZQInjector, Contrast Medium, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2
IZQInjector, Contrast Medium, AutomaticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
49345390003538PackageGS150In Commercial Distribution
09345390003530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4934539000353849345390003538
09345390003530093453900035309345390003530

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
740733993
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09345390003462MEDRAD® Centargo Replacement SpikeCENT-RSCENT-RS2026-08-19
09345390003523MEDRAD® Centargo Patient Line (350 cm)CENT-PL-350CENT-PL-3502026-05-06
49345390003538MEDRAD® Centargo Patient LineCENT-PLCENT-PL2025-12-10
09345390003356MEDRAD® Centargo CT Injection SystemCENT-SYS-OCSCENT-SYS-OCS2025-08-18
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
10841716104210VueJect® V90, 90 cm tubingACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
10841716104227VueJect® V150, 150 cm tubingACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
10841716104234VueJect® Remote DockACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
10841716104241VueJect® Ultrasound Enhancing Agent Delivery SystemACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
00616258028309MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care Inc.DXT2026-10-30
06938327906467GuerbetShenzhen Boon Medical Supply Co., Ltd.DXT2026-10-24
06938327902926Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-08-19
09345390003462MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2026-08-19
09345390003462MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2026-08-19
06938327909888Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909895Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909901Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909918Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
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 LTDIZQ2026-05-06
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
06938327909215Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-03-27
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 LTDIZQ2025-03-28
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08