FDA.report

CARDINAL HEALTH

Primary DI
50195594560360
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
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
50195594560360PackageGS1100In Commercial Distribution
10195594560362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559456036050195594560360
1019559456036210195594560362

GMDN Terms

TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, 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. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature040 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

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
50195594754066CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
20809160371944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
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