FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450429150
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-11133A
Published
2026-10-27
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
10884450429157PackageGS110In Commercial Distribution
20884450429154PackageGS14In Commercial Distribution
00884450429150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445042915710884450429157
2088445042915420884450429154
00884450429150008844504291508844504291500884450429150

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
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12
10884450451790Prelude SNAP™DPLS-1008.52026-09-12
10884450451806Prelude SNAP™DPLS-10082026-09-12
10884450451813Prelude SNAP™DPLS-1009.52026-09-12
10884450451899Prelude SNAP™DPLS-10092026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541814Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-27
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956607590CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956590229CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956603837CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956606982CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608016CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956608214CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956609068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956611351CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956612730CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956614918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956616738CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
B098AMS188920Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
B098AMS199310Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-10-23
00884450499214Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450501023Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450502082Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-22
00884450431641Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-21
10809160541029Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-21
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19