FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450426630
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-13283C
Published
2026-06-03
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
10884450426637PackageGS16In Commercial Distribution
20884450426634PackageGS14In Commercial Distribution
00884450426630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445042663710884450426637
2088445042663420884450426634
00884450426630008844504266308844504266300884450426630

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
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02
00884450376478Merit Medical®Initial ReleaseK09-01002L2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450437438Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
00884450486887Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
10198956320123CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956328938CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956444027CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956468023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956477230CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956486843CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956489073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490468CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490529CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956492721CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956496613CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956498662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956500440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
00884450424087Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450435403Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474549Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474556Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474563Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
10198956311282CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956340145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956392281CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956420816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956428089CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956429345CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956436428CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956457140CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956458796CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956462236CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01