FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594387877
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
20-0021C
Catalog number
20-0021C
Device description
ACCESS CHANGE KIT CMMPLS019
Published
2021-11-23
Public version status
Update
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
50195594387875PackageGS130In Commercial Distribution
10195594387877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559438787550195594387875
1019559438787710195594387877

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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
10809160526774HALYARDMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160526781HALYARDMEDICAL 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