FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327492626
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ85355
Catalog number
DYNJ85355
Device description
TRACHEOSTOMY KIT
Published
2023-12-21
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
NXATracheotomy care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXATracheotomy Care KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327492626PackageGS16In Commercial Distribution
10195327492625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532749262640195327492626
1019532749262510195327492625

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10198956196186CARDINAL HEALTHCardinal Health 200, LLCNXA2025-10-16
10198956173842CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
50198956173840CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
10198459480379MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
40198459480370MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
10198956110816CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
50198956110814CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
10198459359217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
40198459359218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
10198459324130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
40198459324131Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
10198459295102Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
40198459295103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
10197106964163CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
50197106964161CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
10198459276743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
10653160998846Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2025-03-02
40198459276744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
40653160998847Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2025-03-02
10198459241659Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-01-19
10198459194214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
40198459194215Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
10653160998006Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-10-13
40653160998007Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.NXA2024-10-13
10198459140839Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
40198459140830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
10197106676844CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
50197106676842CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
10198459062438Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06
40198459062439Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06