FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594804266
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
39-5425F
Catalog number
39-5425F
Device description
VAGINAL PREP KIT
Published
2022-09-08
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
OJUSkin prep tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJUSkin Prep TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594804266PackageGS124In Commercial Distribution
10195594804268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559480426650195594804266
1019559480426810195594804268

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient preparation kitA collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956392845CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-24
50198956392364CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-19
50198956326468CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-16
50198956377057CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-06
50198956301243CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956387414CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956387735CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956346770CARDINAL HEALTHCardinal Health 200, LLCOJU2026-02-23
50198956318272CARDINAL HEALTHCardinal Health 200, LLCOJU2026-02-09
50198956280395CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-30
50198956178289CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-26
50198956326888CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-23
50198956258356CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-15
50198956178296CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-13
50198956275209CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-17
50198956299335CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-17
50198956228687CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-11
50198956253870CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-09
50198956259766CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-09
50198956259223CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-28
50198956274219CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-28
50198956234763CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-17
50198956232462CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-13
20809160504373Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OJU2025-11-13
50198956228021CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-11
40612479277555McKessonMCKESSON MEDICAL-SURGICAL INC.OJU2025-08-27
40612479277593McKessonMCKESSON MEDICAL-SURGICAL INC.OJU2025-08-27
40198459415679MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18
40198459477943MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18
40198459481667MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18