CARDINAL HEALTH

Primary DI
50888439331613
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA23ECRM1
Catalog number
SBA23ECRM1
Device description
ECMO
Published
2019-01-07
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
OEUCardiopulmonary bypass catheter kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEUCardiopulmonary Bypass Catheter KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439331613PackageGS14In Commercial Distribution
10888439331615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843933161350888439331613
1088843933161510888439331615

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439331615CARDINAL HEALTHCardinal Health 200, LLCOEU2019-01-07
10888439140279CARDINAL HEALTHCardinal Health 200, LLCOEU2018-09-06
10887488211473CARDINAL HEALTHCardinal Health 200, LLCOEU2016-06-03
10887488426099CARDINAL HEALTHCardinal Health 200, LLCOEU2016-03-21