FDA.report

Medline Industries, Inc.

Primary DI
10653160392774
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
EBSI1518B
Device description
VAD SILVER KIT
Published
2026-03-17
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

Related Records

Product Codes

CodeName
OXQDressing Change Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160392774PrimaryGS10

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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 DIBrandModelCatalogPublished
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10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956336535CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-24
50198956352887CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956352979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956353198CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956366310CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956375367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956379686CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956381153CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956401981CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956404739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956351842CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-19
10653160392767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392804Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392811Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392866Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392873Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
50198956348378CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
50198956351804CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
10653160392699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392705Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
50198956297478CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-10
50198956390360CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-10