FDA.reportPublic FDA data

DiamondTOUCH™

Primary DI
00884450021255
Brand
DiamondTOUCH™
Company
Merit Medical Systems, Inc.
Model
B
Catalog number
IN9135
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXTInjector and syringe, angiographic
MAVSyringe, balloon inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2
MAVSyringe, Balloon InflationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450021252PackageGS15In Commercial Distribution
20884450021259PackageGS12In Commercial Distribution
00884450021255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445002125210884450021252
2088445002125920884450021259
00884450021255008844500212558844500212550884450021255

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29
00884450022597One-Step™DOSC-4F-10LNH2026-07-29
00884450022603One-Step™DOSC-4F-7L2026-07-29
00884450022665One-Step™DOSC-4F-7S2026-07-29
00884450022689One-Step™DOSC-5F-10LNH2026-07-29
00884450022764One-Step™DOSC-5F-7L2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938327909888Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909895Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909901Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909918Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
06938327909215Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-03-27
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