FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594355203
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-3744G
Catalog number
03-3744G
Device description
LVAD DRESSING CHANGE HIGH RISK
Published
2022-02-10
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594355201PackageGS130In Commercial Distribution
10195594355203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559435520150195594355201
1019559435520310195594355203

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
10653160393979MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394051MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394082MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394112MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394129MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394181MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394211MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10198956334281CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956500518CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956504097CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956481251CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-16
10198956524590CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-16
10198956481312CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956518995CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956519176CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10809160526866MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OXQ2026-07-08
10198956520233CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956520547CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956481282CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10198956481305CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10653160394037MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-22
10653160393764MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10653160393849MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10198956477278CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-08
10198956487765CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-05
10198956428942CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956476639CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956479852CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10653160393726MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10653160393733MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27