FDA.reportPublic FDA data

Guerbet

Primary DI
06938327906924
Brand
Guerbet
Company
Shenzhen Boon Medical Supply Co., Ltd.
Model
371202
Catalog number
241826
Device description
12h CT 200/200ml Syringes(Green)
Published
2025-06-27
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241109000Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.2024-08-22DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26938327906928PackageGS120In Commercial Distribution
06938327906924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693832790692826938327906928
06938327906924069383279069246938327906924

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system syringeA component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in-barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. It is typically made of plastic materials and can be reused for several patients, e.g., up to five patients. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
9999999999client.complaint@guerbet.com

Regulatory Flags#

DUNS number
529174252
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
06938327909215Sinton Medical Products100103-IHS-DC2012026-03-27
06938327901905DeRoyal100113-IDRS-DCD2012025-11-28
26938327901909DeRoyal100113-IDRS-DCD2012025-11-28
06938327909185Sinton Medical Products100108-WHS-NC200 Plus2025-11-17
06938327909192Sinton Medical Products400102-20HT-LY15022025-11-17
06938327909208Sinton Medical Products400102-25HT-LY18022025-11-17
26938327909189Sinton Medical Products100108-WHS-NC200 Plus2025-11-17
16938327909199Sinton Medical Products400102-20HT-LY15022025-11-17
16938327909205Sinton Medical Products400102-25HT-LY18022025-11-17
06938327909666Sinton Medical Products400204-3HT-L2502F2024-10-31
06938327909765Sinton Medical Products700206-2HT-SK500F2021-11-13
06938327909772Sinton Medical Products700207-1HT-SK501F2021-11-13
06938327909789Sinton Medical Products700207-2HT-SK502F2024-01-16
06938327909796Sinton Medical Products700207-2AHT-SK501FC2024-01-16
06938327909802Sinton Medical Products700206-2AHT-SK500F2024-01-16
06938327909819Sinton Medical Products700207-1AHT-SK501FS2024-01-16
06938327909826Sinton Medical Products700207-2BHT-SK500FC2024-01-16
06938327909833Sinton Medical Products700206-1AHT-SK200F2024-02-28
06938327909840Sinton Medical Products700207-1CHT-SK501FS2024-10-31
06938327909857Sinton Medical Products700207-2CHT-SK501FC2024-10-31

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