FDA.reportPublic FDA data

MEDRAD® Centargo Replacement Spike

Primary DI
09345390003462
Brand
MEDRAD® Centargo Replacement Spike
Company
IMAXEON PTY LTD
Model
CENT-RS
Catalog number
CENT-RS
Device description
ASSY,SPIKE,BORLA,CENTARGO,GILERO (91328741)
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
49345390003460PackageGS150In Commercial Distribution
09345390003462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4934539000346049345390003460
09345390003462093453900034629345390003462

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
740733993
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
06938327902926Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-08-19
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 LTDDXT2026-05-06
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDIZQ2026-05-06
06938327909215Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-03-27
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-12-10
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
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
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