FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594402969
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA31CBNM2
Catalog number
SBA31CBNM2
Device description
CORD BLOOD KIT
Published
2021-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MYKKit, cord blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYKKit, Cord Blood CollectionUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594402967PackageGS130In Commercial Distribution
10195594402969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559440296750195594402967
1019559440296910195594402969

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380213851CARDINAL HEALTHCH33225CH332252026-11-02
10192253025316Monoject888151123588815112352021-09-17
20884521014999Monoject888151131088815113102016-09-24
20884521014937Monoject888151111088815111102016-09-24
10192253046526Kendall55546BAMD55546BAMD2023-10-09
10192253046786Kendall55588BAMDX55588BAMDX2025-09-09
10885380031687PROTEXIS2D72NT65X2D72NT65X2018-04-13
10192253025309Monoject888151120188815112012021-09-17
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50195594402967CARDINAL HEALTHCardinal Health 200, LLCMYK2021-10-20
10888439509298CARDINAL HEALTHCardinal Health 200, LLCMYK2019-05-31
50888439509296CARDINAL HEALTHCardinal Health 200, LLCMYK2019-05-31
B098PS1000Aligned Medical SolutionsAligned Medical SolutionsMYK2018-11-14
B098PS1001Aligned Medical SolutionsAligned Medical SolutionsMYK2018-11-14
10885425366132CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27
50885425366130CARDINAL HEALTHCardinal Health 200, LLCMYK2016-09-27