FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956390324
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-4856M
Catalog number
03-4856M
Device description
HEALTH FIRST CVC DRESSING KIT
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEZCentral venous catheter dressing change kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956390322PackageGS150In Commercial Distribution
10198956390324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895639032250198956390322
1019895639032410198956390324

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
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
10198956537392CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-08-26
00197998001246Solventum™ Tegaderm™Solventum US LLCPEZ2026-08-23
00197998001277Solventum™ Tegaderm™Solventum US LLCPEZ2026-08-23
10198956542709CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-08-18
10809160527054Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-14
10809160527030MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-13
10198956510074CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-07-09
10809160526873MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-08
10809160526750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160526774Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160526781Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160522790Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-06-05
10198956473324CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-05-08
10198956085138CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-30
10198956435254CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-27
10198956459212CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-21
10198956334274CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956340183CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956415966CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956359444CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-06
10198956416161CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-06
10198956363496CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-31
10198956412163CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
10198956348332CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
10198956391864CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
10198956408791CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-10
10198956372887CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-02
10198956348325CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-23
10198956339118CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-13
10198956339989CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-02