FDA.reportPublic FDA data

Bardex® Lubricath® Foley Catheter

Primary DI
00801741017759
Brand
Bardex® Lubricath® Foley Catheter
Company
C. R. Bard, Inc.
Model
01237526
Catalog number
01237526
Device description
Bardex® Lubricath® Foley Catheter 75cc Balloon Medium Length Round Tip Lubricious Coated
Published
2016-08-06
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

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
10801741017756PackageGS112In Commercial Distribution
00801741017759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101775610801741017756
00801741017759008017410177598017410177590801741017759

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 Gauge26French

Contacts#

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

Regulatory Flags#

DUNS number
016898496
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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
00801741046544Bardex® 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
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