FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489860450
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC3084
Catalog number
DYNDC3084
Device description
DIALYSIS KIT
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489860451PackageGS125In Commercial Distribution
10193489860450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348986045140193489860451
1019348986045010193489860450

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)633-5463customerservice@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
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956504134CARDINAL HEALTHCardinal Health 200, LLCFKG2026-07-09
10198956441064CARDINAL HEALTHCardinal Health 200, LLCFKG2026-05-08
10198956094727CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
10197106986493CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
10653160378686MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
00653160378689MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
10653160376583MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
00653160376586MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
10653160375173MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
10653160373582MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
10809160422687Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
10653160372400MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
10197106349861CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
10197106347188CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
10653160361008MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
10197106092453CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
10653160359630MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
10197106230992CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25