FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106741030
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-2242D
Catalog number
03-2242D
Device description
HMH CENTRAL LINE DRESSING TRAY
Published
2024-09-27
Public version status
Update
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
50197106741038PackageGS155In Commercial Distribution
10197106741030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674103850197106741038
1019710674103010197106741030

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10198956178281CARDINAL HEALTH11-7005A11-7005A2026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956322349CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-29
10198956269514CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-05
10198956269354CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-19