FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956537545
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01A5005P
Catalog number
01A5005P
Device description
NYCHH IV START KIT EXT SET
Published
2026-08-26
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
50198956537543PackageGS1100In Commercial Distribution
10198956537545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653754350198956537543
1019895653754510198956537545

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 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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09555240405210IV Start KitITL ASIA PACIFIC SDN. BHD.LRS2023-06-28
10193489112672MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-25