FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489886917
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
CDS840455L
Catalog number
CDS840455L
Device description
MAD OPEN HEART
Published
2021-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489886917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348988691710193489886917

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20197344159069MEDLINEMDT12091XXLMDT12091XXL2026-03-03
20197344159113MEDLINEMDTZ1210949ADMDTZ1210949AD2026-03-03
10653160393924MEDLINEBSIPIV1022ABSIPIV1022A2026-10-05
10653160394372MEDLINEARTNC245ARTNC2452026-10-05
10653160394631MEDLINECVI4880CCVI4880C2026-10-05
10653160395010MEDLINEBSIPIV1020ABSIPIV1020A2026-10-05
10653160395034MEDLINEARTNC246ARTNC2462026-10-05
10653160395195MEDLINEARTNC247ARTNC2472026-10-05
20080196182029GeminiGEM2115SGEM2115S2016-10-14
20080196182104GeminiGEM2118SGEM2118S2016-10-14
20080196182241GeminiGEM2120SGEM2120S2016-10-14
20080196182357GeminiGEM2124SGEM2124S2016-10-14
20080196183248GeminiGEM2130SGEM2130S2016-10-14
10653160349082MEDLINEDYNDV2513DYNDV25132021-11-18
10653160351849MEDLINEDYNDV2482BDYNDV2482B2022-04-04
10888277237681MEDLINEDYNDR1135DYNDR11352016-09-29
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376713Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
00884450428344Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-06
10198956171954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956480865CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956511262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956539518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956543188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956550964CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956551169CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956564626CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956566866CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956568471CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956577510CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956581401CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956584020CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589445CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956589902CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956592933CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593473CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956593855CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956594838CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595392CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956595453CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596238CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596580CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596658CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06
10198956596719CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-06