FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489239188
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1726
Catalog number
DYKE1726
Device description
ENDO PROCEDURE KIT
Published
2022-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
40193489239189PackageGS120In Commercial Distribution
10193489239188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348923918940193489239189
1019348923918810193489239188

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

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
10193489988529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988628Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988635Medline 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