FDA.reportPublic FDA data

Medline

Primary DI
10889942467082
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
URO170218
Catalog number
URO170218
Device description
TTL1LYR 18FR10ML LATEX UM TRAY
Published
2022-11-30
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
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942467083PackageGS110In Commercial Distribution
10889942467082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994246708340889942467083
1088994246708210889942467082

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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains 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
10198956385054CARDINAL HEALTHCardinal Health 200, LLCOHR2026-04-27
10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
10198956094376CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
10809160429389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHR2024-07-10
10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10653160995791Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-12-21
10850053289191SURGYCOSurgyco LLCOHR2023-12-15
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10610075177063ApogeeHOLLISTER INCORPORATEDOHR2023-08-22
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13
10195327245474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-07-29
10653160995517Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-07-29
10195327195236MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10195327242862MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10653160995067Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-04-30