FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450436400
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-10889D
Published
2026-03-06
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
10884450436407PackageGS110In Commercial Distribution
20884450436404PackageGS14In Commercial Distribution
00884450436400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043640710884450436407
2088445043640420884450436404
00884450436400008844504364008844504364000884450436400

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

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
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450163344Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-18
10809160527337HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527375HalyardAVID MEDICAL, INC.OEZ2026-07-17
10809160527429HalyardAVID MEDICAL, INC.OEZ2026-07-17
00884450161777Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
00884450432075Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
10198956319929CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956326484CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956382381CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956395886CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956424524CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956446533CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956502376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956505148CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956508378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956512740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956513648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956514508CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956519992CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956525337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526242CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527782CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527898CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528130CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528277CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16