FDA.reportPublic FDA data

Medical Imaging Solutions Intl.

Primary DI
00850014500092
Brand
Medical Imaging Solutions Intl.
Company
MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY
Model
200101
Device description
"1-200ml syringe, 1-60"" coiled tubing, 1 fill straw UM"
Published
2021-01-15
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
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
20850014500096PackageGS150In Commercial Distribution
00850014500092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001450009620850014500096
00850014500092008500145000928500145000920850014500092

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
Ethylene Oxide

Regulatory Flags#

DUNS number
005179271
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014500016Medical Imaging Solutions Intl.1002012021-01-15
00850014500023Medical Imaging Solutions Intl.1002012021-01-15
00850014500030Medical Imaging Solutions Intl.1001012021-01-15
00850014500047Medical Imaging Solutions Intl.1001012021-01-15
00850014500054Medical Imaging Solutions Intl.100301T2021-01-15
00850014500061Medical Imaging Solutions Intl.100301T2021-01-15
00850014500078Medical Imaging Solutions Intl.100302T2021-01-15
00850014500085Medical Imaging Solutions Intl.100302T2021-01-15
00850014500108Medical Imaging Solutions Intl.2001012021-01-15
00850014500115Medical Imaging Solutions Intl.200105A2021-01-15
00850014500122Medical Imaging Solutions Intl.200107D2021-01-15
00850014500139Medical Imaging Solutions Intl.2001082021-01-15
00850014500146Medical Imaging Solutions Intl.2001092021-01-15
00850014500153Medical Imaging Solutions Intl.2002012021-01-15
00850014500160Medical Imaging Solutions Intl.2003012021-01-15
00850014500177Medical Imaging Solutions Intl.200301A2021-01-15
00850014500184Medical Imaging Solutions Intl.4001012021-01-15
00850014500191Medical Imaging Solutions Intl.400103D2021-01-15
00850014500207Medical Imaging Solutions Intl.4001082021-01-15
00850014500214Medical Imaging Solutions Intl.4001092021-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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