FDA.reportPublic FDA data

Medline

Primary DI
40080196997597
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJWE2234
Catalog number
DYNJWE2234
Device description
DRAIN,WOUND,ROUND,24FR,5/16",FULL-FLUTED
Published
2021-01-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196997597PackageGS110In Commercial Distribution
10080196997596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019699759740080196997597
1008019699759610080196997596

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00822045001503SAM ThoraSite®SAM Medical ProductsGBX2025-12-12
20885380182430JACKSON-PRATTCardinal Health 200, LLCGBX2025-09-12
20885380182508CARDINAL HEALTHCardinal Health 200, LLCGBX2025-09-12
34026704933373PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-08
34026704933380PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
24026704933406PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
10884450581008ReSolve®Merit Medical Systems, Inc.GBX2025-05-23
10661392032009LSL HEALTHCARELSL Industries, LLCGBX2025-05-16
10884450779900ReSolve®Merit Medical Systems, Inc.GBX2025-05-13
00840456205891JMUJMU DENTAL, INCGBX2025-05-02
24026704933345PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933352PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933413PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933468PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933472PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933489PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
24026704933499PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933502PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933519PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933526PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933311PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933328PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933338PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933366PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933390PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933420PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933437PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933444PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933458PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
10884450719937ReSolve Mini™Merit Medical Systems, Inc.GBX2025-03-15