FDA.report

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

Related Records

Product Codes

CodeName
OFZBlood specimen collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OFZBlood Specimen Collection Kit (Excludes Hiv Testing)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50198956098075PackageGS1100In Commercial Distribution
10198956098077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019895609807550198956098075
1019895609807710198956098077

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00860193001730KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
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50195594560360CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
50888439848838CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
00860193001709AlloSure Specimen Collection KitCAREDX, INC.OFZ2020-04-30
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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
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