FDA.reportPublic FDA data

Medline

Primary DI
40080196997061
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND11520
Catalog number
DYND11520
Device description
TRAY,FOLEY,100% SILICONE,18FR,10ML,LF
Published
2016-10-14
Public version status
Update
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
40080196997061PackageGS110In Commercial Distribution
10080196997060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019699706140080196997061
1008019699706010080196997060

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Storage And Handling#

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

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
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07
08034139292878Thoracic Catheter, Straight Fr 33REDAX SPAGBX2021-05-07
08034139293806Thoracic Catheter, Angled Fr 30REDAX SPAGBX2021-05-07
08034139293813Thoracic Catheter, Angled Fr 33REDAX SPAGBX2021-05-07
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294568Flat Drain type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294575Flat Drain type Jackson-Pratt w/trocar 4x10 mmREDAX SPAGBX2021-05-07
08034139294582Flat Drain type Jackson-Pratt 4x13 mmREDAX SPAGBX2021-05-07
08034139294599Flat Drain type Jackson-Pratt w/trocar 4x13 mmREDAX SPAGBX2021-05-07
08034139294629Round Drain type Jackson-Pratt Fr 7REDAX SPAGBX2021-05-07
08034139294643Round Drain type Jackson-Pratt Fr 10REDAX SPAGBX2021-05-07
08034139294650Round Drain type Jackson-Pratt w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294698Round Drain type Jackson-Pratt w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294933Spiral Drain Round Fluted Drain w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294940Spiral Drain Round Fluted Drain w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294964Spiral Drain Round Fluted Drain w/trocar Fr 12REDAX SPAGBX2021-05-07
08034139294971Spiral Drain Round Fluted Drain Fr 7REDAX SPAGBX2021-05-07
08034139295008Spiral Drain Round Fluted Drain Fr 10REDAX SPAGBX2021-05-07
08034139295022Spiral Drain Round Fluted Drain Fr 15REDAX SPAGBX2021-05-07
08034139295039Spiral Drain Round Fluted Drain Fr 19REDAX SPAGBX2021-05-07
08034139295053Spiral Drain Round Fluted Drain Fr 24REDAX SPAGBX2021-05-07
08034139295060Flat Fluted Drain 4x10 mmREDAX SPAGBX2021-05-07