FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106735433
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-0210A
Catalog number
03-0210A
Device description
PORT DRESSING CHANGE KIT
Published
2024-09-25
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106735433PackageGS188In Commercial Distribution
10197106735435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710673543350197106735433
1019710673543510197106735435

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

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489111224MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-08-04
10193489190106MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190113MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190120MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190151MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190397MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489112689MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-11-01
10193489112528MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112597MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112603MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112610MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112627MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112641MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112658MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112184MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112191MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112207MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112214MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112221MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112238MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112115MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112122MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112139MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112146MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112177MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489111798MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111804MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111729MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-17
10193489111767MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-17
10193489111705MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-09