FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106741830
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
20-0813A
Catalog number
20-0813A
Device description
ONC PORT KIT
Published
2024-10-22
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

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
50197106741830PackageGS148In Commercial Distribution
10197106741832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674183050197106741830
1019710674183210197106741832

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537848HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537978HalyardAVID MEDICAL, INC.OEZ2026-09-20
10809160537626HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537671HalyardAVID MEDICAL, INC.OEZ2026-09-19
10809160537770HalyardAVID MEDICAL, INC.OEZ2026-09-19
00884450265260Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450277164Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450306635Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450336922Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450428955Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450431740Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450432068Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450442050Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450486931Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
00884450488867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-18
10809160536315HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160536407HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537091HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537107HalyardAVID MEDICAL, INC.OEZ2026-09-18
10809160537312HalyardAVID MEDICAL, INC.OEZ2026-09-18
B098AMS195520Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-18
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04