FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450430118
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-05157A
Published
2026-08-27
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
10884450430115PackageGS125In Commercial Distribution
20884450430112PackageGS12In Commercial Distribution
00884450430118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043011510884450430115
2088445043011220884450430112
00884450430118008844504301188844504301180884450430118

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450501696Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-04
10198956428102CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956509320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956532205CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956546646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956550285CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956555556CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956556331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956561779CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956562530CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956563377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956563476CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956564961CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956565142CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956569195CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956569874CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956570344CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956570351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956571723CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956573536CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956574472CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956574489CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-04
10198956504486CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956514706CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956523401CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956537743CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956547155CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956549456CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956560307CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956562400CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26