FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450789292
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450789292
Catalog number
K10T-04484G
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPDUniversal drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPDUniversal Drainage TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450789292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450789292008844507892928844507892920884450789292

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.

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
00884450111185Merit Medical®Merit Medical Systems, Inc.PPD2026-05-02
10198956325166CARDINAL HEALTHCardinal Health 200, LLCPPD2026-03-10
00884450112120Merit Medical®Merit Medical Systems, Inc.PPD2026-02-25
00884450111109Merit Medical®Merit Medical Systems, Inc.PPD2026-02-20
00884450111857Merit Medical®Merit Medical Systems, Inc.PPD2026-02-14
00884450112090Merit Medical®Merit Medical Systems, Inc.PPD2026-02-05
00884450112540Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
00884450113240Merit Medical®Merit Medical Systems, Inc.PPD2026-01-20
00884450112267Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450113479Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450034002Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450108758Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450110546Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450108499Merit Medical®Merit Medical Systems, Inc.PPD2025-12-16
00884450110782Waste Management KitMerit Medical Systems, Inc.PPD2025-12-12
00884450113509Merit Medical®Merit Medical Systems, Inc.PPD2025-12-12
00884450105474Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450105849Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450034057Merit Medical®Merit Medical Systems, Inc.PPD2025-11-22
00884450034071Merit Medical®Merit Medical Systems, Inc.PPD2025-11-06
00884450034385Merit Medical®Merit Medical Systems, Inc.PPD2025-10-28
00884450102077Merit Medical®Merit Medical Systems, Inc.PPD2025-10-28
00884450033258Merit Medical®Merit Medical Systems, Inc.PPD2025-09-23
00884450033241Merit Medical®Merit Medical Systems, Inc.PPD2025-09-20
00884450034026Merit Medical®Merit Medical Systems, Inc.PPD2025-09-12
00884450033494Merit Medical®Merit Medical Systems, Inc.PPD2025-08-08
00884450093399Merit Medical®Merit Medical Systems, Inc.PPD2025-06-13
10197106451656CARDINAL HEALTHCardinal Health 200, LLCPPD2023-11-20
10197106048702CARDINAL HEALTHCardinal Health 200, LLCPPD2022-12-29
10195594427795CARDINAL HEALTHCardinal Health 200, LLCPPD2021-11-12