FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594754066
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-4561C
Catalog number
17-4561C
Device description
BLOOD CULTURE TRAY
Published
2022-08-04
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
OFZBlood specimen collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFZBlood Specimen Collection Kit (Excludes Hiv Testing)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594754066PackageGS1100In Commercial Distribution
10195594754068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559475406650195594754066
1019559475406810195594754068

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810185250196TherapakTherapak LLCOFZ2025-08-11
50198956098075CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
50198956070576CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
20809160416591Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
00810094575854CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
07312058462857TherapakTherapak LLCOFZ2022-12-21
00860193001730KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
00860193001747KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
20809160371944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
50195594560360CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
50888439848838CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
00860193001709AlloSure Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001716Allomap Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001723HeartCare Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00191072107268ACSAMERICAN CONTRACT SYSTEMS, INC.OFZ2020-04-06
00812277035247CuraplexBOUND TREE MEDICAL, LLCOFZ2019-07-01
20809160240776Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
25060498451530Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
20809160149451Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2017-06-06
25060498450137Motion Medical DistributingHaslam Medical, Inc.OFZ2017-01-05
25060498450144Motion Medical DistributingHaslam Medical, Inc.OFZ2016-11-09
25060498450120Motion Medical DistributingHaslam Medical, Inc.OFZ2016-10-03
20809160105396MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFZ2016-09-17
20809160087722MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFZ2016-09-07
20809160016784Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20
20809160004552Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20
20809160007409Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20
20809160009625Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20
20809160009984Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20
20809160011772Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2016-08-20