FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450313367
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450313367
Catalog number
K09T-11985B
Published
2019-03-21
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450313367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450313367008844503133678844503133670884450313367

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system manifold kitA collection of sterile devices designed to provide an interface between a contrast medium injection system and an angiographic patient catheter for the delivery of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is intended to maximize the creation of the optimal connection for fluid delivery. It typically consists of an injection fitting that is connected to the contrast medium injection system, a pressure transducer cartridge, a check valve and tubing; it is typically made of plastic materials. 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
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450163344Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-18
10809160527337HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527375HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527429HalyardAVID MEDICAL, INC.OEZ2026-07-17
00884450161777Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
00884450432075Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
10198956319929CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956326484CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956382381CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956395886CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956424524CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956446533CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956502376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956505148CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956508378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956512740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956513648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956514508CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956519992CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956525337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526242CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527782CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527898CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528130CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528277CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16