FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450031469
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-02709B
Published
2026-10-07
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
10884450031466PackageGS120In Commercial Distribution
20884450031463PackageGS14In Commercial Distribution
00884450031469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003146610884450031466
2088445003146320884450031463
00884450031469008844500314698844500314690884450031469

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
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160540121HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540176HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540183HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540060HalyardAVID MEDICAL, INC.OEZ2026-10-07
00884450376713Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
00884450428344Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
10198956171954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956480865CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956511262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956539518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956543188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956550964CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956551169CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956564626CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956566866CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956568471CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956577510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956581401CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956584020CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589445CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589902CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592933CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593473CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593855CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956594838CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595392CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595453CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596238CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06