FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956098075
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-4561E
Catalog number
17-4561E
Device description
BLOOD CULTURE TRAY
Published
2025-06-30
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
50198956098075PackageGS1100In Commercial Distribution
10198956098077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895609807550198956098075
1019895609807710198956098077

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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
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
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