FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489412673
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKL1335B
Catalog number
DYKL1335B
Device description
MATERNITY KIT
Published
2023-06-08
Public version status
New
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489412674PackageGS16In Commercial Distribution
10193489412673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348941267440193489412674
1019348941267310193489412673

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489215052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489410006Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489414646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489415773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489417289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489418187Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419290Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419429Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489423730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489424089Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426229Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426410Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489430202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489443288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489446159Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489447286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454666Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489455946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489456899Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489459319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10080196849710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489420562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24
10193489426274Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-08-04
10193489431551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-16
10193489451238Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02
10193489457896Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02
10193489457957Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-01-02