FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327421916
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
5C4150M
Catalog number
5C4150M
Device description
PD TRNSFR SET CHNG DIALYSIS KT
Published
2023-06-25
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
PEVDialysis administration kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327421916PackageGS120In Commercial Distribution
10195327421915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532742191640195327421916
1019532742191510195327421915

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
true
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
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
20809160418113Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2024-01-30
40195327538591Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
40195327544820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
40653160995778Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
40653160995785Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
40195327572663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
40195327572670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
40195327531547Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
40195327535200Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
40195327535217Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
50197106403271CARDINAL HEALTHCardinal Health 200, LLCPEV2023-09-14
40195327429752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-07-29
40195327459223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-07-23
50197106294916CARDINAL HEALTHCardinal Health 200, LLCPEV2023-06-15
50197106292073CARDINAL HEALTHCardinal Health 200, LLCPEV2023-06-08
40195327421398Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-06-04