FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450420065
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-14003B
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10884450420062PackageGS110In Commercial Distribution
20884450420069PackageGS14In Commercial Distribution
00884450420065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445042006210884450420062
2088445042006920884450420069
00884450420065008844504200658844504200650884450420065

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.

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
00884450161692Merit Medical®Initial ReleaseK09-10791D2026-10-22
00884450428238Merit Medical®Initial ReleaseK10-00125M2026-10-22
00884450435700Merit Medical®Initial ReleaseK10-04943A2026-10-22
00884450499214Merit Medical®Initial ReleaseK12T-02975G2026-10-22
00884450501023Merit Medical®Initial ReleaseK12T-127572026-10-22
00884450501047Merit Medical®Initial ReleaseK10-06118G2026-10-22
00884450501054Merit Medical®Initial ReleaseK09-05248Q2026-10-22
00884450501078Merit Medical®Initial ReleaseK10-00389R2026-10-22
00884450501085Merit Medical®Initial ReleaseK09-14184F2026-10-22
00884450502075Merit Medical®Initial ReleaseK10-03143F2026-10-22
00884450502082Merit Medical®Initial ReleaseK12T-09122J2026-10-22
00884450502556Merit Medical®Initial ReleaseK09-144532026-10-22
00884450502891Merit Medical®Initial ReleaseK09-05181J2026-10-22
00884450502921Merit Medical®Initial ReleaseK09-12476F2026-10-22
00884450502938Merit Medical®Initial ReleaseK09-14208C2026-10-22
00884450502952Merit Medical®Initial ReleaseK09-10938F2026-10-22
00884450502969Merit Medical®Initial ReleaseK09-13923C2026-10-22
10884450485672EndoAVF® Access KitInitial ReleaseK21-000922026-10-22
00884450431641Merit Medical®Initial ReleaseK12-11132C2026-10-21
10884450439392Prelude IDeal™JPID4F11018NTPD2026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450161692Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450501054Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450501085Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502556Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502891Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502921Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502938Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502952Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450502969Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
10809160541142HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541180HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541197HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541210HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541265HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541272HalyardAVID MEDICAL, INC.OEZ2026-10-22
10809160541005HalyardAVID MEDICAL, INC.OEZ2026-10-21
10809160541067Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEZ2026-10-21
10809160541074HalyardAVID MEDICAL, INC.OEZ2026-10-21
00884450113059Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-20
10809160540909HalyardAVID MEDICAL, INC.OEZ2026-10-20
10198956441811CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956462328CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956516922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956559226CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956584266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589629CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589896CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602151CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602205CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19