FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450489338
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450489338
Catalog number
K12T-10514A
Published
2020-07-22
Public version status
Update
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450489338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450489338008844504893388844504893380884450489338

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603160040
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450180082Merit Medical®Initial ReleaseK09-13310C2026-10-09
10884450614409Prelude®DPSI-4F-11-0252026-10-09
00884450031469Merit Medical®Initial ReleaseK09-02709B2026-10-07
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956420526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956504578CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956517332CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956542228CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956551251CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956556157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956581715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956589049CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956590557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956592711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956593947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956594685CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956596726CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956598362CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956598843CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956602540CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
B098AMS183880Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-05
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596597CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30