FDA.reportPublic FDA data

Disposable High Pressure Syringe

Primary DI
06970286900339
Brand
Disposable High Pressure Syringe
Company
Union Medical Shenzhen Co.,LTD.
Model
SMR301
Published
2018-12-26
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

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
K170279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170279000Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd.2017-12-12DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970286900339PackageGS150In Commercial Distribution
06970286900094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970286900339069702869003396970286900339
06970286900094069702869000946970286900094

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544445008
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
06970286900018Disposable High Pressure SyringeSMR1012018-12-26
06970286900056Disposable High Pressure SyringeSMR2012018-12-26
06970286900094Disposable High Pressure SyringeSMR3012018-12-26
06970286900100Disposable High Pressure SyringeSMR3022018-12-26
06970286900117Disposable High Pressure SyringeSLF1012018-12-26
06970286900124Disposable High Pressure SyringeSLF1022018-12-26
06970286900148Disposable High Pressure SyringeSLF2022018-12-26
06970286900155Disposable High Pressure SyringeSLF3012018-12-26
06970286900254Disposable High Pressure SyringeSEZ1012018-12-26
06970286900346Disposable High Pressure SyringeSLF1032018-12-26
06970286900513Disposable High Pressure SyringeSEZ1032018-12-26
06970286900520Disposable High Pressure SyringeSEZ1082018-12-26
06970286900537Disposable High Pressure SyringeSEZ1092018-12-26
06970286900544Disposable High Pressure SyringeSLF1072018-12-26
06970286900551Disposable High Pressure SyringeSLF1082018-12-26
06970286900568Disposable High Pressure SyringeSEZ3012018-12-26
06970286900575Disposable High Pressure SyringeSLF3022018-12-26
06970286900315Disposable High Pressure SyringeSMR1012018-12-26
06970286900322Disposable High Pressure SyringeSMR2012018-12-26
06970286900377Disposable High Pressure SyringeSMR3022018-12-26

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