FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106831021
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01-8278A
Catalog number
01-8278A
Device description
IV START KIT
Published
2024-12-31
Public version status
Update
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
LAAHigh pressure liquid chromatography, benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAAHigh Pressure Liquid Chromatography, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106831029PackageGS1100In Commercial Distribution
10197106831021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710683102950197106831029
1019710683102110197106831021

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. 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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50197106831029CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
10197106819371CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
50197106819379CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
10197106873083CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
50197106873081CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
10197106782743CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
50197106782741CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
10197106782132CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106792957CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106782130CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106792955CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106743584CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-09
50197106743582CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-09
10197106616956CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
50197106616954CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
10197106669815CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
50197106669813CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
10197106668979CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
50197106668977CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
10197106652381CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
50197106652389CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
10197106600436CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106650110CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106600434CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106650118CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106577974CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
10197106621868CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106577972CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106621866CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
10197106639214CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-17