FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956070578
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-4561D
Catalog number
17-4561D
Device description
BLOOD CULTURE TRAY
Published
2025-05-13
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
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
50198956070576PackageGS1100In Commercial Distribution
10198956070578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895607057650198956070576
1019895607057810198956070578

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

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
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
10195594560362CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
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