FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450435820
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450435823
Catalog number
K22C-00037A
Published
2019-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10884450435820PackageGS18In Commercial Distribution
00884450435823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043582010884450435820
00884450435823008844504358238844504358230884450435823

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
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
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
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956378254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956421394CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956422308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956460485CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956466968CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956473164CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956484542CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486478CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486669CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486768CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956488267CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956490567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
00884450474587Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-23
00884450220696Merit Medical®Merit Medical Systems, Inc.OEQ2026-03-24
50198956300499CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956339840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956418514CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956421804CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956431957CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956274721CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956325331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956332872CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956343342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23