FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450502044
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450502044
Catalog number
K12T-05320B
Published
2020-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00884450502044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450502044008844505020448844505020440884450502044

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603160040
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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
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

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
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