FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439509296
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
33-5327B
Catalog number
33-5327B
Device description
PLACENTAL BLOOD DRAW TRAY
Published
2019-05-31
Public version status
Update
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
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
50888439509296PackageGS120In Commercial Distribution
10888439509298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843950929650888439509296
1088843950929810888439509298

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
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
10195594402969CARDINAL HEALTHCardinal Health 200, LLCMYK2021-10-20
50195594402967CARDINAL HEALTHCardinal Health 200, LLCMYK2021-10-20
10888439509298CARDINAL 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