FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450032107
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-07828W
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10884450032104PackageGS13In Commercial Distribution
20884450032101PackageGS12In Commercial Distribution
00884450032107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003210410884450032104
2088445003210120884450032101
00884450032107008844500321078844500321070884450032107

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
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
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956549340CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956553217CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956558618CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956559684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956561861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562417CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956563704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956564848CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956566767CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956568457CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956569522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570535CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570573CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571570CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571884CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956572379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04