FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450045039
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450045039
Catalog number
K10-00702A
Published
2018-09-13
Public version status
New
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
PPDUniversal drainage tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450045036PackageGS115In Commercial Distribution
20884450045033PackageGS14In Commercial Distribution
00884450045039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445004503610884450045036
2088445004503320884450045033
00884450045039008844500450398844500450390884450045039

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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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