FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395690
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC3636
Catalog number
DYNDC3636
Device description
PORT DRESSING CHANGE KIT
Published
2026-10-29
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
00653160395693PackageGS120In Commercial Distribution
10653160395690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395693006531603956936531603956930653160395693
1065316039569010653160395690

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)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
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
00197344205281CURADCUR47451RBCUR47451RB2026-10-29
00884389108362CURADCUR4025RCUR4025R2026-10-29
00884389108393CURADCUR4135RCUR4135R2026-10-29
00888277187088CURADCUR4125RCUR4125R2026-10-29
10197344148608MEDLINERTDCIVDHGRTDCIVDHG2026-10-29
10197344148615MEDLINERTDCIVDHNRTDCIVDHN2026-10-29
10197344148622MEDLINERTDCIVDHPRTDCIVDHP2026-10-29
10197344148639MEDLINERTDCIVDHRRTDCIVDHR2026-10-29
10197344148646MEDLINERTDCIVDHYRTDCIVDHY2026-10-29
10197344148653MEDLINERTDCIVDHZRTDCIVDHZ2026-10-29
10197344219278MEDLINEDYNDSCL3000RDYNDSCL3000R2026-10-29
10197344223862MEDLINEDYSNR24OVCOLDDYSNR24OVCOLD2026-10-29
10653160395768MEDLINECVI5130BCVI5130B2026-10-29
10653160395874MEDLINEEBSI1161BEBSI1161B2026-10-29
10653160395935MEDLINEDYNDH2410DYNDH24102026-10-29
10653160395966MEDLINEEBSI1729BEBSI1729B2026-10-29
10653160396017MEDLINEEBSI1427BEBSI1427B2026-10-29
10653160396024MEDLINEDYNDC3648DYNDC36482026-10-29
10653160396031MEDLINEEBSI1840AEBSI1840A2026-10-29
20197344223388MEDLINEL2USAXLFL2USAXLF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007725VYGONVygon CorporationOXQ2026-10-29
10198956435292CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956592247CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956593633CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10198956606821CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-29
10653160395874MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396017MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396024MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160396031MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-29
10653160395461MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395713MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395720MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395782MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395805MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395812MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395911MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10198956594739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956596276CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15