FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439924396
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV34BHML5
Catalog number
SCV34BHML5
Device description
HEART PACK BAMO DOCTORS
Published
2020-10-12
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
50888439924396PackageGS11In Commercial Distribution
10888439924398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843992439650888439924396
1088843992439810888439924398

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160540121HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540176HalyardAVID MEDICAL, INC.OEZ2026-10-08
10809160540183HalyardAVID MEDICAL, INC.OEZ2026-10-08
00884450031469Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-07
10809160540060HalyardAVID MEDICAL, INC.OEZ2026-10-07
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