FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450431535
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-04729B
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450431532PackageGS16In Commercial Distribution
20884450431539PackageGS14In Commercial Distribution
00884450431535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043153210884450431532
2088445043153920884450431539
00884450431535008844504315358844504315350884450431535

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
00884450163351Merit Medical®Initial ReleaseK09-11704C2026-11-05
00884450420034Merit Medical®Initial ReleaseK09-14260A2026-11-05
00884450420263Merit Medical®Initial ReleaseK09-11289A2026-11-05
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
00884450099346Merit Medical®Merit Medical Systems, Inc.OEQ2026-11-05
10198956421349CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956437074CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956494855CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956511132CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956552746CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956568358CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956570719CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956577121CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956590182CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956591806CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956597150CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956599215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956599611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956602779CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956603479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956604353CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956604391CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956605558CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956606876CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956606906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956607750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956607873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956608306CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956609594CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610057CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610415CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610699CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956610743CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05
10198956611078CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-11-05