FDA.reportPublic FDA data

Disposable High Pressure Injector Syringe

Primary DI
06971352280331
Brand
Disposable High Pressure Injector Syringe
Company
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
Model
200150B
Device description
1-150ml Syringe, 1-J-type Tubular Medicine Aspirator
Published
2021-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K152906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152906000Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd.2016-11-22DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971352280331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971352280331069713522803316971352280331

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418798733
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
06971352286128Yeso-med1ml 0.4×12.72022-08-23
06975442097878CareTouch1ml 2022-08-23
06975442097885CareTouch1ml 2022-08-23
06975442097892CareTouch3ml2022-08-23
06975442097908CareTouch3ml 2022-08-23
06975442097915CareTouch5ml2022-08-23
06975442097922CareTouch5ml 2022-08-23
06975442097939CareTouch10ml2022-08-23
06975442097946CareTouch10ml 2022-08-23
06975442097953CareTouch3ml 0.8×252022-08-23
06975442097960CareTouch3ml 0.8×382022-08-23
06975442097977CareTouch3ml 0.9×252022-08-23
06975442097984CareTouch3ml 0.9×382022-08-23
06975442097991CareTouch3ml 0.6×252022-08-23
06975442098004CareTouch3ml 0.6×382022-08-23
06975442098011CareTouch3ml 0.5×162022-08-23
06975442098028CareTouch3ml 0.5×252022-08-23
06975442098035CareTouch3ml 0.5×382022-08-23
06975442098042CareTouch3ml 0.45×252022-08-23
06975442098059CareTouch3ml 0.45×382022-08-23

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