FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956537392
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-4909E
Catalog number
03-4909E
Device description
CTRL LINE CHG DRSG CHANGE KIT
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
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
50198956537390PackageGS140In Commercial Distribution
10198956537392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653739050198956537390
1019895653739210198956537392

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
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
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
10198956390324CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
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