FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395454
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
EBSI1886A
Catalog number
EBSI1886A
Device description
BETADINE KIT
Published
2026-10-14
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160395457PackageGS120In Commercial Distribution
10653160395454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395457006531603954576531603954570653160395457
1065316039545410653160395454

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
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
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15
10653160394433MEDLINEEBSI1364BEBSI1364B2026-10-15
10653160394457MEDLINEEBSI1118BEBSI1118B2026-10-15
10653160394488MEDLINEDYNDV2796DYNDV27962026-10-15
10653160394556MEDLINEDYNDV2517ADYNDV2517A2026-10-15
10653160394587MEDLINEDYNDC3625DYNDC36252026-10-15
10653160394617MEDLINEDYNDH2389DYNDH23892026-10-15
10653160394662MEDLINEDYNDC3628DYNDC36282026-10-15
10653160394679MEDLINEDYNDC3627DYNDC36272026-10-15
10653160394693MEDLINEEBSI1567BEBSI1567B2026-10-15
10653160394877MEDLINEDYNDV2421ADYNDV2421A2026-10-15
10653160394907MEDLINEDYNDC3622ADYNDC3622A2026-10-15
10653160394969MEDLINEEBSI1147AEBSI1147A2026-10-15
10653160394983MEDLINEDYNDC3619DYNDC36192026-10-15
10653160395027MEDLINEEBSI1148AEBSI1148A2026-10-15
10653160395072MEDLINEDYNDV2812DYNDV28122026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395300MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395362MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395379MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395515MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395522MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395546MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395560MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395638MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10198956592223CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-12