FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450177997
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450177990
Catalog number
K10-04751
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
10884450177997PackageGS16In Commercial Distribution
20884450177994PackageGS14In Commercial Distribution
00884450177990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445017799710884450177997
2088445017799420884450177994
00884450177990008844501779908844501779900884450177990

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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