FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450486771
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450486771
Catalog number
K09T-13362A
Published
2020-05-07
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
00884450486771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450486771008844504867718844504867710884450486771

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
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12
10884450451790Prelude SNAP™DPLS-1008.52026-09-12
10884450451806Prelude SNAP™DPLS-10082026-09-12
10884450451813Prelude SNAP™DPLS-1009.52026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542057HALYARDMEDICAL ACTION INDUSTRIES INC.OEZ2026-10-28
10809160542149HalyardMEDICAL ACTION INDUSTRIES INC.OEZ2026-10-28
00884450436677Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-27
10809160541821HALYARDMEDICAL ACTION INDUSTRIES INC.OEZ2026-10-27
10198956611023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956612846CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956613379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956614062CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956616875CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10198956621510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-26
10809160541562HalyardAVID MEDICAL, INC.OEZ2026-10-26
10809160541579HalyardAVID MEDICAL, INC.OEZ2026-10-26
10809160541616HalyardAVID MEDICAL, INC.OEZ2026-10-26
00884450431542Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-24
10198956409552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956571259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956579378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956592049CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956601147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956602687CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956604179CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956605459CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606029CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956606609CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956607620CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608474CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956608818CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609198CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956609730CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23