FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10080196991488
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND11855
Catalog number
DYND11855
Device description
TRAY, FOLEY, SILI-ELAST, 14FR
Published
2016-09-29
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
PPBFoley catheter kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196991489PackageGS110In Commercial Distribution
10080196991488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019699148940080196991489
1008019699148810080196991488

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@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
10192253068191DoverCardinal Health 200, LLCPPB2026-01-15
10192253068207DoverCardinal Health 200, LLCPPB2026-01-15
10192253030525DoverCardinal Health 200, LLCPPB2024-12-20
10192253030532DoverCardinal Health 200, LLCPPB2024-12-20
10193489987126Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489987133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489987119Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987294Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987300Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987386Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987393Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987416Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987423Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987430Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987447Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987577Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987676Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987683Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987690Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987706Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987942Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489988048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489988055Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30