FDA.report

CARDINAL HEALTH

Primary DI
50197106572564
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
40-1143K
Catalog number
40-1143K
Device description
RADIAL ARTERIAL LINE TRAY
Published
2024-04-19
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
OFKPercutaneous atrial catheter kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFKPercutaneous Atrial Catheter KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106572564PackageGS130In Commercial Distribution
10197106572566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710657256450197106572564
1019710657256610197106572566

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956074123CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
50198956010770CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
50197106927944CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
00685447019466VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019558VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019565VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019572VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019589VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019596VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019602VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019619VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019626VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019633VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019640VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019657VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019664VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019671VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019688VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019695VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019701VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019718VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019725VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019732VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019749VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019756VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019763VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25