FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450507708
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450507704
Catalog number
K09-12305A
Published
2020-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10884450507701PackageGS110In Commercial Distribution
20884450507708PackageGS14In Commercial Distribution
00884450507704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445050770110884450507701
2088445050770820884450507708
00884450507704008844505077048844505077040884450507704

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
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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