FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450584347
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450584347
Catalog number
K09T-13384B
Published
2021-07-14
Public version status
New
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
00884450584347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450584347008844505843478844505843470884450584347

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

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
00884450385760Merit Medical®Initial ReleaseK12-00076F2026-10-13
00884450431603Merit Medical®Initial ReleaseK09-13548A2026-10-13
10884450306915Performa®B6MPPROW-1452026-10-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450431603Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-13
10198956541658CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-13
10198956601437CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-13
10198956605077CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-13
10198956077348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956137547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956194632CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956471887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956518421CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956538467CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956541672CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956554085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956569362CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956575042CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956576957CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956581227CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956584372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586987CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956587212CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956591783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956596481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599178CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599185CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599383CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599451CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600324CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12