FDA.reportPublic FDA data

Dover

Primary DI
20884521015545
Brand
Dover
Company
Cardinal Health, Inc.
Model
6165C
Catalog number
6165C
Device description
Hydrogel Coated Latex Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-Connected to 2000 mL Drainage Bag with Luer-Slip Sampling
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCATHETER, RETENTION TYPE, BALLOON
PPGUrinary Drainage Collection Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521015545PackageGS110In Commercial Distribution
10884521015548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101554520884521015545
1088452101554810884521015548

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071085DoverCardinal Health 200, LLCPPG2026-06-24
10192253071092DoverCardinal Health 200, LLCPPG2026-06-24
10192253068023DoverCardinal Health 200, LLCPPG2026-06-23
10192253068030DoverCardinal Health 200, LLCPPG2026-06-23
10192253068047DoverCardinal Health 200, LLCPPG2026-06-23
10192253068054DoverCardinal Health 200, LLCPPG2026-06-23
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
10192253031843DoverCardinal Health 200, LLCPPG2026-03-20
10192253031799DoverCardinal Health 200, LLCPPG2026-02-24
10192253031881DoverCardinal Health 200, LLCPPG2026-02-24
10192253031935DoverCardinal Health 200, LLCPPG2026-02-24
10192253032048DoverCardinal Health 200, LLCPPG2026-02-24
10192253032093DoverCardinal Health 200, LLCPPG2026-02-24
10192253032017DoverCardinal Health 200, LLCPPG2025-05-29
10192253032062DoverCardinal Health 200, LLCPPG2025-05-29
10192253027969DoverCardinal Health 200, LLCPPG2025-05-14
10192253031287DoverCardinal Health 200, LLCPPG2025-03-20
10192253031584DoverCardinal Health 200, LLCPPG2025-03-20
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253028065DoverCardinal Health 200, LLCPPG2024-12-20
10192253028096DoverCardinal Health 200, LLCPPG2024-12-20
10192253028102DoverCardinal Health 200, LLCPPG2024-12-20
10192253028119DoverCardinal Health 200, LLCPPG2024-12-20
10192253028126DoverCardinal Health 200, LLCPPG2024-12-20
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20