FDA.reportPublic FDA data

Medline

Primary DI
10884389942628
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND19144
Catalog number
DYND19144
Device description
SET,IRRIGATION,4-LEAD
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJHSystem, irrigation, urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJHSystem, Irrigation, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389942629PackageGS120In Commercial Distribution
10884389942628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438994262940884389942629
1088438994262810884389942628

GMDN Terms#

Term, Definition table
TermDefinition
Urological irrigation setA collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.LJH2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.LJH2026-05-05
10704411021544AMSure® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
10704411016090AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10704411016106AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016091AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016107AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10080196993819MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993826MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993833MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993810MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993834MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
00628725001012MED-RXCanadian Hospital Specialties LimitedLJH2016-10-19
00628725001043MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
00628725001050MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
10884389942604MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10884389942611MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
00817183020363Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
40884389942605MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942612MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942629MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10817183020360Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
00085412000978NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412000985NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001005NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001029NABAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001036NABAXTER INTERNATIONAL INC.LJH2016-09-24