FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594118851
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV56OH912
Catalog number
SCV56OH912
Device description
HEART PACK
Published
2021-05-26
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
50195594118851PackageGS11In Commercial Distribution
10195594118853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559411885150195594118851
1019559411885310195594118853

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956587298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-01
10809160539569HalyardAVID MEDICAL, INC.OEZ2026-10-01
10197106980361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956485105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956563247CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956565913CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956568167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956575745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956578999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956589209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956590083CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592285CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592599CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593688CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593961CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956594623CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956595255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596078CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956598225CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10809160539392HALYARDAVID MEDICAL, INC.OEZ2026-09-30
10809160539408HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539460HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539484HalyardAVID MEDICAL, INC.OEZ2026-09-30
00884450421383Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450431917Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450500002Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29