FDA.reportPublic FDA data

Dover

Primary DI
10192253066258
Brand
Dover
Company
Cardinal Health 200, LLC
Model
20522ICC
Catalog number
20522ICC
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 22 FR (7.3 MM), 5 CC, 2-WAY
Published
2024-09-04
Public version status
Update
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
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
20192253066255PackageGS110In Commercial Distribution
50192253066256PackageGS110In Commercial Distribution
10192253066258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306625520192253066255
5019225306625650192253066256
1019225306625810192253066258

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

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