FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450163351
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-11704C
Published
2026-11-05
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
10884450163358PackageGS16In Commercial Distribution
20884450163355PackageGS12In Commercial Distribution
00884450163351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445016335810884450163358
2088445016335520884450163355
00884450163351008844501633518844501633510884450163351

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
00884450099346Merit Medical®Initial ReleaseK05-02879B2026-11-05
00884450420034Merit Medical®Initial ReleaseK09-14260A2026-11-05
00884450420263Merit Medical®Initial ReleaseK09-11289A2026-11-05
00884450431535Merit Medical®Initial ReleaseK12-04729B2026-11-05
00884450436530Merit Medical®Initial ReleaseK09-05978D2026-11-05
00884450436974Merit Medical®Initial ReleaseK09-09344D2026-11-05
00884450508763Merit Medical®Initial ReleaseK09-13864D2026-11-05
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450431443Merit Medical®Initial ReleaseK08-03296A2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
00884450503829Merit Medical®Initial ReleaseK09-13310D2026-11-04
00884450794739DuraMax®AH7871030290152026-11-03
00884450838228Prelude Roadster™APG8F45S2026-11-03
00884450839355Prelude Roadster™APG7F90SX2026-11-04
10884450708467Prelude®FPSI-7F-11-038-18G2026-11-03
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30
00884450499221Merit MAK™GMAK401N2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450420034Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-05
00884450420263Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-05
00884450436530Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-05
00884450436974Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-05
00884450508763Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-05
10198956347021CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956419568CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956446434CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956459885CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956506107CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956514591CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956521766CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956523999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956541481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956546639CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956547308CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956549395CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956552081CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956553569CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956553651CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956558656CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956571501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956581104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956583146CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956584242CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956584310CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956584358CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956587014CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956591035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05
10198956591851CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-05