FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594560362
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-4561B
Catalog number
17-4561B
Device description
BLOOD CULTURE
Published
2022-02-24
Public version status
Update
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
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
50195594560360PackageGS1100In Commercial Distribution
10195594560362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559456036050195594560360
1019559456036210195594560362

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 Temperature040 Degrees Celsius

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810185250189TherapakTherapak LLCOFZ2025-08-11
00810185250196TherapakTherapak LLCOFZ2025-08-11
10198956098077CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
50198956098075CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
10198956070578CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
50198956070576CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
10809160416594Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
20809160416591Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
00810094575809CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
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
10195594754068CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
50195594754066CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
10809160371947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
20809160371944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
50195594560360CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
10888439848830CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
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
10809160240779Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
20809160240776Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
15060498451533Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
25060498451530Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
10809160149454Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2017-06-06