FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10198459329401
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJT3494
Catalog number
DYNJT3494
Device description
MARGIN DIALYSIS PACK
Published
2025-04-18
Public version status
New
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
PEVDialysis administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459329402PackageGS15In Commercial Distribution
10198459329401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845932940240198459329402
1019845932940110198459329401

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

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
10809160520291Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEV2026-04-28
10198956419100CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
10809160508428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
10198459467608MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
10198459394973MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
10198459337536MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
10198459283796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
10653160998808Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
10197106795675CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
10198459149375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10198459149382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10195327571122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327594022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327653460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
10197106506998CARDINAL HEALTHCardinal Health 200, LLCPEV2024-02-13
10195327625160Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-02-11