FDA.reportPublic FDA data

Sinton Medical Products

Primary DI
26938327902869
Brand
Sinton Medical Products
Company
Shenzhen Boon Medical Supply Co., Ltd.
Model
700107-1
Catalog number
HT-SK501
Device description
1-21" Transfer Set with Swabable Valve
Published
2018-08-15
Public version status
Update
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151960000Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016-01-07DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938327902862PackageGS150In Commercial Distribution
26938327902869PackageGS12In Commercial Distribution
06938327902865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693832790286216938327902862
2693832790286926938327902869
06938327902865069383279028656938327902865

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(954)380-8873sales@sintonmedicalproducts.com

Regulatory Flags#

DUNS number
529174252
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
false
Sterilization required before use
false

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
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
10193489066005NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066012NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05