FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327548354
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ83254A
Catalog number
DYNJ83254A
Device description
BURN PACK
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
OJJBurn kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327548354PackageGS14In Commercial Distribution
10195327548353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532754835440195327548354
1019532754835310195327548353

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
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717121831Regard™ROI CPS, LLCOJJ2025-01-28
10195327596453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627782Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627836Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327632724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327651381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327655921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327672584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-04-28
10195327623074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-02-11
10194717118619Regard™ROI CPS, LLCOJJ2024-02-07
10195327578848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-24
10195327494445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327494513Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327548353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327523282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327523763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327513375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-01
10195327471576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-08-13
10195327443856Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-07-29
10195327376161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-06-13
10195327409968Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-05-21
10195327328047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-29
10197106103937CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-25
10195327328337Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327328375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327320928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15
10195327325725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15
10197106102732CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-13
10195594600457CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-09
10197106099360CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-04