FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489688238
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKL1389
Catalog number
DYKL1389
Device description
NICU BABY KIT
Published
2019-06-09
Public version status
Update
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
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
40193489688239PackageGS112In Commercial Distribution
10193489688238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348968823940193489688239
1019348968823810193489688238

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
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10198956380127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956383647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956388406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956416802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956426146CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956427242CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956430174CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956437265CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956441910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444775CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956445680CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956453753CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956455528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956456624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457713CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956460638CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956461741CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956462014CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465831CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25