FDA.reportPublic FDA data

Dover

Primary DI
20192253025719
Brand
Dover
Company
Cardinal Health 200, LLC
Model
8888760520
Catalog number
8888760520
Device description
100% SILICONE FOLEY CATHETER, 5 CC, 2-WAY, 20 FR (6.7 MM)
Published
2023-11-21
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
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253025719PackageGS110In Commercial Distribution
50192253025710PackageGS16In Commercial Distribution
10192253025712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225302571920192253025719
5019225302571050192253025710
1019225302571210192253025712

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge20French
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
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
true
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
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253068229DoverCardinal Health 200, LLCEZL2026-01-15
50192253068236DoverCardinal Health 200, LLCEZL2026-01-15
50192253067659DoverCardinal Health 200, LLCEZL2025-04-14
20192253067665DoverCardinal Health 200, LLCEZL2025-04-14
50192253067673DoverCardinal Health 200, LLCEZL2025-04-14
20192253067689DoverCardinal Health 200, LLCEZL2025-04-14
20884522000014Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000024Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000031Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000048Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000055Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000062Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
00850029182016Egress Safety CatheterInnoCare Urologics, LLCEZL2025-03-19
27290110066516Covidien AGDEGANIA SILICONE LTDEZL2025-03-04
27290110066479Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066486Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066493Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066509Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066523Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
16936881165051All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785653All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785684All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785714All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785752All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785790All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785820All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785844All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785875All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785882All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785912All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05