FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450346136
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450346136
Catalog number
K12T-05813
Published
2018-09-13
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
00884450346136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450346136008844503461368844503461360884450346136

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
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450220306Merit Medical®Merit Medical Systems, Inc.OEQ2026-06-03
00884450487006Merit Medical®Merit Medical Systems, Inc.OEQ2026-06-03
10198956334915CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956477018CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956489462CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956491656CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956493223CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956493445CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-03
10198956428324CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956444355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956460973CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956469037CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956471696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956476240CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956477711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956487505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956488977CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489295CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956489561CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490307CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956490420CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956491342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492493CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956492875CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956493544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
10198956494190CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-01
00884450474570Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-29
00884450430057Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
00884450487549Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
10809160522035HALYARDAVID MEDICAL, INC.OEQ2026-05-27