FDA.report

Dover

Primary DI
20192253030461
Brand
Dover
Company
Cardinal Health 200, LLC
Model
20514ICC
Catalog number
20514ICC
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 14 FR (4.7 MM), 5 CC, 2-WAY
Published
2024-02-29
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

Related Records

Product Codes

CodeName
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications

CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253030461PackageGS110In Commercial Distribution
50192253030462PackageGS110In Commercial Distribution
10192253030464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225303046120192253030461
5019225303046250192253030462
1019225303046410192253030464

GMDN Terms

TermDefinition
Indwelling urethral drainage balloon catheter, antimicrobialA flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Sterilization Methods

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

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50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
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50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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Primary DIBrandCompanyProduct codePublished
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20192253067689DoverCardinal Health 200, LLCEZL2025-04-14
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10884522000024Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
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10884522000062Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
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