FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956585423
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01C6551B
Catalog number
01C6551B
Device description
IV START STATLOCK NO DRSG 1682
Published
2026-10-06
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
50198956585421PackageGS150In Commercial Distribution
10198956585423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658542150198956585421
1019895658542310198956585423

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956588332CARDINAL HEALTHCardinal Health 200, LLCLRS2026-10-06
10809160539965Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-10-06
10653160393924MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-05
10653160393900MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-01
10198956570887CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-29
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