FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160394600
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
EBSI1745A
Catalog number
EBSI1745A
Device description
LVAD KIT
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160394603PackageGS120In Commercial Distribution
10653160394600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160394603006531603946036531603946030653160394603
1065316039460010653160394600

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956566644CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956568280CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956578357CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956581654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956586178CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956580268CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-22
10198956562271CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956573550CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956584426CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10653160394389MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394419MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394525MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394648MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394761MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394891MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394990MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160395140MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10198956538856CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956539617CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956556744CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956564367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956541474CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956548701CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956557758CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10653160394358MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-26
10198956539358CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-18
10198956499348CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956538511CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956490895CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-31
10198956339019CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-27