FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450431542
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-10472B
Published
2026-10-24
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
10884450431549PackageGS110In Commercial Distribution
20884450431546PackageGS14In Commercial Distribution
00884450431542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043154910884450431549
2088445043154620884450431546
00884450431542008844504315428844504315420884450431542

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
00884450459386MAK-NV™DMAK-NV-0182026-10-23
00884450499252Merit S-MAK™HS-MAK401N2026-10-24
10884450438777Prelude® Short SheathBPSS-7F-4MT2026-10-23
10884450834340Prelude EASE™GPHR4F11018SS2026-10-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956609860CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610026CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956610125CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956611160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956612440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956613645CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10198956617643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-23
10809160541340HalyardAVID MEDICAL, INC.OEZ2026-10-23
10809160541364HalyardAVID MEDICAL, INC.OEZ2026-10-23
10809160541371HalyardAVID MEDICAL, INC.OEZ2026-10-23
10809160541395HalyardAVID MEDICAL, INC.OEZ2026-10-23
10809160541425HalyardAVID MEDICAL, INC.OEZ2026-10-23
00884450161692Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22
00884450501054Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-22