FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594883720
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ORO8108619
Catalog number
ORO8108619
Device description
KIT,OB DLVRY, BERGAN MERCY,6 C
Published
2022-10-05
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
50195594883728PackageGS16In Commercial Distribution
10195594883720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559488372850195594883728
1019559488372010195594883720

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.

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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
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