FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327241484
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKL1845
Catalog number
DYKL1845
Device description
KIT, OB ADMIN
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327241484PackageGS110In Commercial Distribution
10195327241483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532724148440195327241484
1019532724148310195327241483

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10809160523087HalyardAVID MEDICAL, INC.OKV2026-06-09
10809160523117HalyardAVID MEDICAL, INC.OKV2026-06-09
10198956454101CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-08
10809160522837HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522851HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522868HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522882HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522974HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522998HalyardAVID MEDICAL, INC.OKV2026-06-08
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02
10198956488229CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-01
10809160522165HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522257HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522141HalyardAVID MEDICAL, INC.OKV2026-05-29
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08