FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450310519
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450310519
Catalog number
K20T-00001B
Published
2019-03-21
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450310519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450310519008844503105198844503105190884450310519

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); 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
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
10195327465865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327537302Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327544317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327482886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-10-15
10195327495756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-09-17
10195327479107Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327480264Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327481292Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327443726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-29
10195327449223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327454401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327442521Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-25
10195327272562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327275440Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327279950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327280055Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327265892Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266356Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327418144Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420895Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327423360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327407650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-28
10195327402808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406097Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407728Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14