FDA.reportPublic FDA data

Dover

Primary DI
10192253029987
Brand
Dover
Company
Cardinal Health 200, LLC
Model
5558492046
Catalog number
5558492046
Device description
Dover Urethral PVC Catheter
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253029985PrimaryGS10
10192253029987Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302998550192253029985
1019225302998710192253029987

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, antimicrobialA flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal; it is also coated with an antibiotic or antimicrobial agent to help prevent infection of the urinary tract. This is a reusable device on the same patient for a limited period of time.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
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
24026704942057RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942060RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942077RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942088RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942095RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942101RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942114RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942125RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942138RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942149RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942152RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942163RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942170RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942183RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
20192253024255DoverCardinal Health 200, LLCKOD2026-03-20
50192253024263DoverCardinal Health 200, LLCKOD2026-03-20
50192253024270DoverCardinal Health 200, LLCKOD2026-03-20
50192253024300DoverCardinal Health 200, LLCKOD2026-03-20
20885380202596DoverCardinal Health 200, LLCKOD2026-03-20
50850058254673EZ-Advancer®HR PHARMACEUTICALS INC.KOD2026-03-06
04026704937158RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937166RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937172RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937180RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937196RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937203RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
20854913006185Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006192Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006154Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16
20854913006161Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16