FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450113240
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K10-04701A
Published
2026-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10884450113247PackageGS110In Commercial Distribution
20884450113244PackageGS14In Commercial Distribution
00884450113240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445011324710884450113247
2088445011324420884450113244
00884450113240008844501132408844501132400884450113240

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.

Regulatory Flags#

DUNS number
184763290
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
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450428474Merit Medical®Merit Medical Systems, Inc.PPD2026-08-19
00884450432365Merit Medical®Merit Medical Systems, Inc.PPD2026-08-18
00884450428245Merit Medical®Merit Medical Systems, Inc.PPD2026-08-15
00884450488775Merit Medical®Merit Medical Systems, Inc.PPD2026-08-14
00884450499207Merit Medical®Merit Medical Systems, Inc.PPD2026-07-30
00884450383865Merit Medical®Merit Medical Systems, Inc.PPD2026-07-25
00884450431764Merit Medical®Merit Medical Systems, Inc.PPD2026-07-22
00884450434482Merit Medical®Merit Medical Systems, Inc.PPD2026-07-14
00884450492956Merit Medical®Merit Medical Systems, Inc.PPD2026-07-11
00884450467039Merit Medical®Merit Medical Systems, Inc.PPD2026-07-07
00884450438480Merit Medical®Merit Medical Systems, Inc.PPD2026-07-03
00884450486337Merit Medical®Merit Medical Systems, Inc.PPD2026-07-03
00884450436202Merit Medical®Merit Medical Systems, Inc.PPD2026-06-25
00884450383896Merit Medical®Merit Medical Systems, Inc.PPD2026-06-24
00884450486993Merit Medical®Merit Medical Systems, Inc.PPD2026-06-09
00884450110270Merit Drainage Depot™Merit Medical Systems, Inc.PPD2026-06-06
00884450467183Merit Medical®Merit Medical Systems, Inc.PPD2026-06-02
00884450487679Merit Medical®Merit Medical Systems, Inc.PPD2026-05-28
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
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