FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956559448
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01-8426E
Catalog number
01-8426E
Device description
IV START KIT
Published
2026-09-04
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

Product Codes#

Code, Name table
CodeName
LRSI.V. start kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956559446PackageGS1100In Commercial Distribution
10198956559448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655944650198956559446
1019895655944810198956559448

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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 Temperature00

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956559523CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-04
10198956537545CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956561113CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956561472CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956534742CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-31
10198956514669CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-27
10198956531581CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-27
10653160394099MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-07-21
10653160394228MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-07-21
10809160527665MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-07-21
10198956436213CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-23
10198956279391CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956481039CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956430235CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956431591CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956480223CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
M689801101006080-110-10 Saline Lock Kit Case of 10Safeguard US Operating, LLCLRS2026-05-29
M68980110150SALINE LOCK KITSafeguard US Operating, LLCLRS2026-05-29
10653160393634MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393665MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393689MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393719MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
M68980100150INTRAVENOUS INFUSION STARTER SETSafeguard US Operating, LLCLRS2026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 20Safeguard US Operating, LLCLRS2026-05-04
10801902225990ARROWTELEFLEX INCORPORATEDLRS2026-04-24
00810010894922Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894939Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894977Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894984Aero-MedAERO-MED, LLCLRS2026-03-17
10197106541029CARDINAL HEALTHCardinal Health 200, LLCLRS2024-03-06