FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160367003
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA3077
Catalog number
DYNDA3077
Device description
CENTRAL LINE DRESSING CHANGE KIT
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160367003PackageGS150In Commercial Distribution
10653160367000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160367003006531603670036531603670030653160367003
1065316036700010653160367000

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
50198956336535CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-24
50198956352887CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956352979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956353198CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956366310CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956375367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956379686CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956381153CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956401981CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956404739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956351842CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-19
10653160392767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392804Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392811Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392866Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392873Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
50198956348378CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
50198956351804CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
10653160392699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392705Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
50198956297478CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-10