FDA.reportPublic FDA data

Dover

Primary DI
10192253029116
Brand
Dover
Company
Cardinal Health 200, LLC
Model
400616
Catalog number
400616
Device description
DOVER VINYL URETHRAL CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 16 FR (5.3 MM)
Published
2025-04-07
Public version status
New
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
KODCATHETER, UROLOGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253029114PackageGS1100In Commercial Distribution
10192253029116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302911450192253029114
1019225302911610192253029116

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, reusableA 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 is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04
10192253066326DoverCardinal Health 200, LLCKOD2024-09-04
10192253066333DoverCardinal Health 200, LLCKOD2024-09-04
10192253066340DoverCardinal Health 200, LLCKOD2024-09-04
10192253066357DoverCardinal Health 200, LLCKOD2024-09-04
10192253066364DoverCardinal Health 200, LLCKOD2024-09-04
10192253066371DoverCardinal Health 200, LLCKOD2024-09-04
10192253066388DoverCardinal Health 200, LLCKOD2024-09-04
10192253066395DoverCardinal Health 200, LLCKOD2024-09-04
10192253066401DoverCardinal Health 200, LLCKOD2024-09-04
10192253024326DoverCardinal Health 200, LLCKOD2024-02-29
10192253024333DoverCardinal Health 200, LLCKOD2024-02-29