FDA.reportPublic FDA data

Dover

Primary DI
10192253030556
Brand
Dover
Company
Cardinal Health 200, LLC
Model
23018ICC
Catalog number
23018ICC
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 18 FR (6.0 MM), 30 CC, 2-WAY
Published
2024-02-29
Public version status
Update
Distribution status
Not 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
EZLCATHETER, RETENTION TYPE, BALLOON
KODCatheter, urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253030553PackageGS110Not in Commercial Distribution
50192253030554PackageGS110Not in Commercial Distribution
10192253030556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225303055320192253030553
5019225303055450192253030554
1019225303055610192253030556

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253024203DoverCardinal Health 200, LLCEZL2024-05-16
10192253024210DoverCardinal Health 200, LLCEZL2024-05-16
10192253024227DoverCardinal Health 200, LLCEZL2024-05-16
10192253024234DoverCardinal Health 200, LLCEZL2024-05-16
10192253024326DoverCardinal Health 200, LLCKOD2024-02-29
10192253024333DoverCardinal Health 200, LLCKOD2024-02-29
10192253024357DoverCardinal Health 200, LLCKOD2024-02-29
10192253024319DoverCardinal Health 200, LLCKOD2024-02-09
10192253024340DoverCardinal Health 200, LLCKOD2024-02-09
10192253025651DoverCardinal Health 200, LLCEZL2023-11-21
10192253025668DoverCardinal Health 200, LLCEZL2023-11-21
10192253025675DoverCardinal Health 200, LLCEZL2023-11-21
10192253025682DoverCardinal Health 200, LLCEZL2023-11-21
10192253025699DoverCardinal Health 200, LLCEZL2023-11-21
10192253025705DoverCardinal Health 200, LLCEZL2023-11-21
10192253025712DoverCardinal Health 200, LLCEZL2023-11-21
10192253025729DoverCardinal Health 200, LLCEZL2023-11-21
10192253025736DoverCardinal Health 200, LLCEZL2023-11-21
10192253025743DoverCardinal Health 200, LLCEZL2023-11-21
10192253025750DoverCardinal Health 200, LLCEZL2023-11-21
10192253025767DoverCardinal Health 200, LLCEZL2023-11-21
10192253025774DoverCardinal Health 200, LLCEZL2023-11-21
10192253025781DoverCardinal Health 200, LLCEZL2023-11-21