FDA.report

Merit Medical®

Primary DI
00884450848425
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K10T-05012J
Published
2024-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PPDUniversal drainage tray

Product Code Classifications

CodeDeviceSpecialtyClass
PPDUniversal Drainage TrayGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884450848425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450848425008844508484258844508484250884450848425

GMDN Terms

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

Regulatory Flags

DUNS number
603160040
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 DIBrandModelCatalogPublished
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450425333Merit Medical®Merit Medical Systems, Inc.PPD2026-03-24
10884450430788Merit Medical®Merit Medical Systems, Inc.PPD2026-03-21
10884450457822Merit Medical®Merit Medical Systems, Inc.PPD2026-03-21
10884450429942Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
10884450431204Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
10884450441487Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
20884450431270Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
10884450431365Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
10884450435363Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
20884450437524Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
20884450428775Merit Medical®Merit Medical Systems, Inc.PPD2026-03-10
50198956325164CARDINAL HEALTHCardinal Health 200, LLCPPD2026-03-10
20884450441934Merit Medical®Merit Medical Systems, Inc.PPD2026-03-05
10884450436353Merit Medical®Merit Medical Systems, Inc.PPD2026-03-03
10884450383886Merit Medical®Merit Medical Systems, Inc.PPD2026-02-28
20884450428744Merit Medical®Merit Medical Systems, Inc.PPD2026-02-28
20884450435414Merit Medical®Merit Medical Systems, Inc.PPD2026-02-26
20884450112124Merit Medical®Merit Medical Systems, Inc.PPD2026-02-25
20884450385627Merit Medical®Merit Medical Systems, Inc.PPD2026-02-21
20884450111103Merit Medical®Merit Medical Systems, Inc.PPD2026-02-20
20884450111851Merit Medical®Merit Medical Systems, Inc.PPD2026-02-14
10884450433680Waste Management KitMerit Medical Systems, Inc.PPD2026-02-14
00884450451601Merit Medical®Merit Medical Systems, Inc.PPD2026-02-07
00884450410776Merit Medical®Merit Medical Systems, Inc.PPD2026-02-06
10884450112097Merit Medical®Merit Medical Systems, Inc.PPD2026-02-05
20884450436398Merit Medical®Merit Medical Systems, Inc.PPD2026-01-29
20884450112544Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
20884450383906Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
10884450209308Merit Medical®Merit Medical Systems, Inc.PPD2026-01-23
20884450428614Merit Medical®Merit Medical Systems, Inc.PPD2026-01-22