FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450480038
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450480038
Catalog number
K12T-10934A
Published
2020-05-15
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
00884450480038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450480038008844504800388844504800380884450480038

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
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
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
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450430057Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
00884450487549Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-28
10809160522035HALYARDAVID MEDICAL, INC.OEQ2026-05-27
10193489078114NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078213NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489078220NAMICMEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489213430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489410013Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489413458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489423372Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489424003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489425147Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489433111Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489448917Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489449198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489453645Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489455885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489456172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489458121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2023-06-08
10193489037517MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037524MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037531MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037548MEDLINEMEDLINE INDUSTRIES, INC.OEQ2023-05-30
10193489037555MedlineMEDLINE INDUSTRIES, INC.OEQ2023-05-30
H65857032425Henry ScheinHENRY SCHEIN, INC.OEQ2023-01-10
10193489444551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-09-04
10193489078121NAMICMEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489248760Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489665727Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-08-04
10193489457223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OEQ2022-07-24