FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450013816
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-14276
Published
2025-05-13
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
10884450013813PackageGS110In Commercial Distribution
20884450013810PackageGS12In Commercial Distribution
00884450013816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445001381310884450013813
2088445001381020884450013810
00884450013816008844500138168844500138160884450013816

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
00884450113059Merit Medical®Initial ReleaseK09-13911C2026-10-20
00884450840610Prelude Roadster™APG5F90S2026-10-20
00884450735916Merit Advance®AAD18N91W-E2026-10-19
10884450735906Merit Advance®AAD18N91W2026-10-19
10884450735920Merit Advance®AAD18T51W2026-10-19
10884450735944Merit Advance®AAD18T51WS2026-10-19
10884450735968Merit Advance®AAD18T71W2026-10-19
10884450735975Merit Advance®AAD18T71WC2026-10-19
10884450735999Merit Advance®AAD18T71W-E2026-10-19
10884450736033Merit Advance®AAD18T71WS2026-10-19
10884450736057Merit Advance®BAD18T71WT2026-10-19
10884450736071Merit Advance®AAD19U41W2026-10-19
10884450736118Merit Advance®AAD19U51W2026-10-19
10884450736132Merit Advance®AAD19U71W2026-10-19
10884450736149Merit Advance®AAD19U71WC2026-10-19
10884450736187Merit Advance®AAD19U71WS2026-10-19
10884450736224Merit Advance®AAD20T41W2026-10-19
10884450736262Merit Advance®AAD20T71W2026-10-19
10884450736309Merit Advance®AAD21T21W2026-10-19
10884450736361Merit Advance®AAD21T41WC2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450113059Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-20
10809160540909HalyardAVID MEDICAL, INC.OEZ2026-10-20
10198956441811CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956462328CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956516922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956559226CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956584266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589629CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589896CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602151CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602205CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602649CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602854CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956603844CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604346CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606432CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606760CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609013CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609129CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956610583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611252CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19