FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450173972
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450173978
Catalog number
K10-03184
Published
2018-09-13
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
PPDUniversal drainage tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450173975PackageGS115In Commercial Distribution
20884450173972PackageGS14In Commercial Distribution
00884450173978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445017397510884450173975
2088445017397220884450173972
00884450173978008844501739788844501739780884450173978

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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
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