FDA.reportPublic FDA data

Medline

Primary DI
10080196509607
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND10440
Catalog number
DYND10440
Device description
KIT,CATH,SELF,MY-CATH,TOUCH-FREE,14FR
Published
2021-09-22
Public version status
New
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
EZDCATHETER, STRAIGHT
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196509608PackageGS160In Commercial Distribution
10080196509607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019650960840080196509608
1008019650960710080196509607

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 product away from direct exposure to light 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22