FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450503829
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-13310D
Published
2026-11-04
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
10884450503826PackageGS16In Commercial Distribution
20884450503823PackageGS12In Commercial Distribution
00884450503829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445050382610884450503826
2088445050382320884450503823
00884450503829008844505038298844505038290884450503829

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
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450431443Merit Medical®Initial ReleaseK08-03296A2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
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
00884450499245Merit MAK™FMAK501N2026-10-30
00884450499870Merit S-MAK™FS-MAK501N2026-10-30
00884450500033Merit Medical®Initial ReleaseK09-05053T2026-10-30
00884450839362Prelude Roadster™APG8F45SX2026-10-30
00884450254677Merit Medical®Initial ReleaseK12-082752026-10-29
00884450838129Prelude Roadster™APG6F45MP2026-10-29
10884450708443Prelude®FPSI-7F-11-035-18G2026-10-29
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450163917Merit Medical®Merit Medical Systems, Inc.OEZ2026-11-04
10198956620377CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-11-03
10809160543078HalyardAVID MEDICAL, INC.OEZ2026-11-03
10809160543153HalyardAVID MEDICAL, INC.OEZ2026-11-03
10809160543177HalyardAVID MEDICAL, INC.OEZ2026-11-03
10809160543191HalyardAVID MEDICAL, INC.OEZ2026-11-03
10809160542439HalyardAVID MEDICAL, INC.OEZ2026-11-02
10809160542491HalyardAVID MEDICAL, INC.OEZ2026-11-02
10809160542705HalyardAVID MEDICAL, INC.OEZ2026-11-02
10809160542743HalyardAVID MEDICAL, INC.OEZ2026-11-02
10809160542750HalyardAVID MEDICAL, INC.OEZ2026-11-02
10809160542842HalyardAVID MEDICAL, INC.OEZ2026-11-02
00884450148174Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-31
00884450500033Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-30
B098AMS201290Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-10-30
10198956423534CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956504745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956533592CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956533653CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956544727CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956549289CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956595224CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956604162CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956607040CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956609952CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612327CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612471CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956612778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29
10198956613430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-29