FDA.reportPublic FDA data

Bard® Foley Catheter Silicone Coated

Primary DI
10801741039574
Brand
Bard® Foley Catheter Silicone Coated
Company
C. R. Bard, Inc.
Model
265712
Catalog number
265712
Device description
Bard®Foley Catheter, Silicone Coated, 5cc Balloon
Published
2016-06-25
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
EZCCATHETER, COUDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741039574PackageGS112In Commercial Distribution
00801741039577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103957410801741039574
00801741039577008017410395778017410395770801741039577

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, 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, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow 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 Gauge12French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704942456RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942463RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942470RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942487RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942494RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942500RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942517RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
10854913006195Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-17
10854913006157Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-16
10854913006119Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10854913006126Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10852141007731COMPACTCATH - LiteCOMPACTCATH, INC.EZC2019-09-01
00801741040665Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040672Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040689Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040696Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040702Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040719Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046520Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046537Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741017735Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017742Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017759Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019333Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019340Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741039096Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741039102Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040238Bard® Foley Catheter Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040252Bard® Urine Meter Foley Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040313Bard® Foley Tray with Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28