FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450501832
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12T-12769
Published
2026-10-14
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
00884450501832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450501832008844505018328844505018320884450501832

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
00884450165652Merit Medical®Initial ReleaseK09-12226A2026-10-15
00884450428283Merit Medical®Initial ReleaseK10-04619B2026-10-15
00884450147290Merit Medical®Initial ReleaseK09-08062B2026-10-14
00884450428214Merit Medical®Initial ReleaseK09-08671B2026-10-14
00884450385760Merit Medical®Initial ReleaseK12-00076F2026-10-13
00884450431603Merit Medical®Initial ReleaseK09-13548A2026-10-13
10884450306915Performa®B6MPPROW-1452026-10-13
00884450180082Merit Medical®Initial ReleaseK09-13310C2026-10-09
10884450614409Prelude®DPSI-4F-11-0252026-10-09
00884450031469Merit Medical®Initial ReleaseK09-02709B2026-10-07
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956571495CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956599406CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956606869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956607446CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956420526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956504578CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956517332CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956542228CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956551251CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956556157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956581715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956589049CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956590557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956592711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956593947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956594685CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06