FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489270372
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ65372
Catalog number
DYNJ65372
Device description
GYN ENDOSCOPY PACK
Published
2022-01-16
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
40193489270373PackageGS14In Commercial Distribution
10193489270372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348927037340193489270373
1019348927037210193489270372

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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
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