FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450193983
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-05312
Published
2026-08-21
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
10884450193980PackageGS125In Commercial Distribution
20884450193987PackageGS14In Commercial Distribution
00884450193983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445019398010884450193980
2088445019398720884450193987
00884450193983008844501939838844501939830884450193983

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
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
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
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450430118Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-27
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
10198956563438CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
10198956564831CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-26
00884450443163Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-25
00884450193457Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-21
10198956513563CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956533707CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956536258CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956554580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
10198956555310CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-08-17
B098AMS14762A0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-16
00884450488843Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-15
B098AMS196570Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-14
B098AMS10132C0Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-08-03
00884450421994Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
00884450500927Merit Medical®Merit Medical Systems, Inc.OEQ2026-08-01
10198956433182CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956456891CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956458840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956485266CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956534698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31
10198956537033CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-31