FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450435403
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-11196A
Published
2026-06-02
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
10884450435400PackageGS16In Commercial Distribution
20884450435407PackageGS14In Commercial Distribution
00884450435403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043540010884450435400
2088445043540720884450435407
00884450435403008844504354038844504354030884450435403

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
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
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
00884450425374Merit Medical®Initial ReleaseK11-01298A2026-05-30
00884450429648Merit Medical®Initial ReleaseK09-13991A2026-05-29
00884450474570Merit Medical®Initial ReleaseK12T-127132026-05-29
00884450826492Fountain®AIS4-90-202026-05-29
10884450587727PowerCURVE®CPWR-2011L2026-05-30
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450424087Merit 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
10198956464049CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956472112CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956473539CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956474208CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956474901CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956475007CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956475434CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956477803CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956478930CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956479876CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956482616CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956484481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956485433CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956485488CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956485556CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956486393CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01