FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160394150
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDJ1156
Catalog number
DYNDJ1156
Device description
TRACH MAINTENANCE KIT
Published
2026-07-21
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160394153PackageGS116In Commercial Distribution
10653160394150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160394153006531603941536531603941530653160394153
1065316039415010653160394150

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.

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
false
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
10193489024517MEDLINEMDS601LSQHFEMDS601LSQHFE2026-07-22
10888277348141MEDLINEMDS601P2MDS601P22026-07-22
10884389145517MEDLINEMDS630BSQMDS630BSQ2016-09-27
10884389145722MEDLINEMDS630LSQMDS630LSQ2016-10-14
10884389145739MEDLINEMDS630MSQMDS630MSQ2016-10-14
10884389818794MEDLINEMDS630XSQMDS630XSQ2016-09-27
20080196162410MEDLINEMPHADJDEPTH2MPHADJDEPTH22023-01-21
10080196395811MEDLINEMPH100030MPH1000302026-07-22
10653160393979MEDLINEDYNDC3596DYNDC35962026-07-21
10653160394051MEDLINEDYNDC3606DYNDC36062026-07-21
10653160394082MEDLINEDYNDC3613DYNDC36132026-07-21
10653160394099MEDLINEIV8880AIV8880A2026-07-21
10653160394105MEDLINEECVC8651ECVC86512026-07-21
10653160394112MEDLINEDYNDC3597DYNDC35972026-07-21
10653160394129MEDLINEDYNDC3611DYNDC36112026-07-21
10653160394167MEDLINEDYNDV2742ADYNDV2742A2026-07-21
10653160394174MEDLINEECVC8390CECVC8390C2026-07-21
10653160394181MEDLINEEBSI1477CEBSI1477C2026-07-21
10653160394211MEDLINEDYNDC3605DYNDC36052026-07-21
10653160394228MEDLINEDYNDV2802DYNDV28022026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394280MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10809160527597HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527627HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527641HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527689HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527696HalyardAVID MEDICAL, INC.LRO2026-07-21
B098AMS15342A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS191710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS192910Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
10198956263611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956333895CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956352261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956361751CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956372801CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956373938CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956382176CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956387614CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956393677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956405356CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20