FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450409190
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450409190
Catalog number
K09-12899
Published
2019-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10884450409197PackageGS110In Commercial Distribution
20884450409194PackageGS12In Commercial Distribution
00884450409190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445040919710884450409197
2088445040919420884450409194
00884450409190008844504091908844504091900884450409190

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
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06
00884450436745Merit Medical®Initial ReleaseK09-13832A2026-06-06
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450107072Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450161746Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
00884450436745Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-06
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10198956491021CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491779CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956491977CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956492561CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
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10198956493636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493759CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05
10198956493971CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-05