FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489843729
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
CDS983513F
Catalog number
CDS983513F
Device description
OPEN HEART CDS
Published
2021-11-15
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
10193489843729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348984372910193489843729

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
Premarket exempt
true
Kit
true
Combination product
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
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450500859Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-08
10809160529386HalyardAVID MEDICAL, INC.OEZ2026-08-08
00884450110164Merit Disposal Depot™Merit Medical Systems, Inc.OEZ2026-08-07
10809160529218HalyardAVID MEDICAL, INC.OEZ2026-08-07
10809160529331HalyardAVID MEDICAL, INC.OEZ2026-08-07
10809160528464HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528563HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528600HalyardAVID MEDICAL, INC.OEZ2026-08-03
00884450447093Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-01
10197106933145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956027596CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956421615CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956439177CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956464292CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956491663CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956500235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956512856CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956513020CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956523746CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956533059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956534162CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956535954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536234CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536937CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538764CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31