FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956570887
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01-2214H
Catalog number
01-2214H
Device description
IV START KIT
Published
2026-09-29
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
50198956570885PackageGS150In Commercial Distribution
10198956570887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657088550198956570885
1019895657088710198956570887

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393900MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-01
10198956585447CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-29
00842209140220NARNORTH AMERICAN RESCUE, LLCLRS2026-09-28
10198956572256CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-25
10809160539019Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-09-25
10198956569799CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10198956573758CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10809160538609HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-22
10809160536773HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18
10809160536810HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18
10198956559448CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-04
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