FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450431740
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-10388B
Published
2026-09-18
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
10884450431747PackageGS110In Commercial Distribution
20884450431744PackageGS14In Commercial Distribution
00884450431740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043174710884450431747
2088445043174420884450431744
00884450431740008844504317408844504317400884450431740

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
00884450030301Merit Medical®Initial ReleaseK08-02374A2026-09-18
00884450101315Merit Medical®Initial ReleaseK12T-11002F2026-09-18
00884450121368Merit Medical®Initial ReleaseK04-00791B2026-09-19
00884450265260Merit Medical®Initial ReleaseK09T-10440D2026-09-18
00884450276808Merit Medical®Initial ReleaseK12T-084642026-09-18
00884450277164Merit Medical®Initial ReleaseK09T-09666F2026-09-18
00884450295854Merit Medical®Initial ReleaseK12T-094032026-09-18
00884450306628Merit Medical®Initial ReleaseK12T-02866A2026-09-18
00884450306635Merit Medical®Initial ReleaseK09T-10276A2026-09-18
00884450306642Merit Medical®Initial ReleaseK12T-03836A2026-09-18
00884450320150Merit Medical®Initial ReleaseK10T-052102026-09-18
00884450320426Merit Medical®Initial ReleaseK10T-053242026-09-18
00884450336922Merit Medical®Initial ReleaseK09T-115672026-09-18
00884450339589Merit Medical®Initial ReleaseK12T-031482026-09-18
00884450340011Merit Medical®Initial ReleaseK12T-035362026-09-18
00884450352069Merit Medical®Initial ReleaseK12T-078402026-09-18
00884450428443Merit Medical®Initial ReleaseK10-01694R2026-09-18
00884450428955Merit Medical®Initial ReleaseK09-14183A2026-09-18
00884450432068Merit Medical®Initial ReleaseK09-07593C2026-09-18
00884450437810Merit Medical®Initial ReleaseK10-00598D2026-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537848HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537978HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537626HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537671HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537770HalyardAVID MEDICAL, INC.OEZ2026-09-19
00884450265260Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450277164Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450306635Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450336922Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450428955Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450432068Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450442050Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450486931Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450488867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
10809160536315HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160536407HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537091HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537107HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537312HalyardAVID MEDICAL, INC.OEZ2026-09-18
B098AMS195520Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-18
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548497CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04