FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106792957
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
END4883413
Catalog number
END4883413
Device description
KIT,ENDO
Published
2024-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50197106792955PackageGS112In Commercial Distribution
10197106792957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710679295550197106792955
1019710679295710197106792957

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10197106831021CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
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
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