FDA.report

Merit Medical®

Primary DI
00884450435533
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K07-00112C
Published
2026-05-23
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

Related Records

Product Codes

CodeName
DXTInjector and syringe, angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450435530PackageGS110In Commercial Distribution
20884450435537PackageGS14In Commercial Distribution
00884450435533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043553010884450435530
2088445043553720884450435537
00884450435533008844504355338844504355330884450435533

GMDN Terms

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.

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24

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10841716102742ACIST VeraPro S100 Multi-Use SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and TransducerACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10884450121433Merit Medical®Merit Medical Systems, Inc.DXT2026-01-13
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40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerBayer Medical Care Inc.DXT2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.DXT2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.DXT2025-12-10
49345390003538MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
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26938327909189Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909199Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909205Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
26945764400148AntmedShenZhen Antmed Co., LtdDXT2025-09-17
26945764400162AntmedShenZhen Antmed Co., LtdDXT2025-09-17
50628725095078MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095085MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095108MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095160MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095177MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095184MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095214MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
00628725095066MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095153MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095207MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095092MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07