FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106726523
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT69FIKVA
Catalog number
SOT69FIKVA
Device description
FOLEY INSERTION PACK
Published
2024-09-03
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
PPBFoley catheter kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106726523PackageGS15In Commercial Distribution
10197106726525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710672652350197106726523
1019710672652510197106726525

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. 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
true
No natural rubber latex
false
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
50192253068199DoverCardinal Health 200, LLCPPB2026-01-15
50192253068205DoverCardinal Health 200, LLCPPB2026-01-15
40198459403096MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-21
40198459407087MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-07
40198459290320Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-16
40198459277710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-02
50192253030523DoverCardinal Health 200, LLCPPB2024-12-20
50192253030530DoverCardinal Health 200, LLCPPB2024-12-20
10195327537319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
10195327537326Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
40195327537334Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
40195327043071Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-06-30
10195327498344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-09-17
40195327444816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-08-06
40195327341863Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-13
40193489987127Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489987134Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988377Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988612Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988629Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988636Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988889Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988896Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40195327165018Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396504Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396528Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396535Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14