FDA.report

Bardex® Lubricath® Foley Catheter

Primary DI
10801741019019
Brand
Bardex® Lubricath® Foley Catheter
Company
C. R. Bard, Inc.
Model
0174L20
Catalog number
0174L20
Device description
Bardex® Lubricath® Latex Foley Catheter 5cc Balloon 3-way Continuous Irrigation Lubricious Coated
Published
2016-06-10
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

Related Records

Contact Domains

Product Codes

CodeName
EZCCATHETER, COUDE

Product Code Classifications

CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741019019PackageGS112In Commercial Distribution
00801741019012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101901910801741019019
00801741019012008017410190128017410190120801741019012

GMDN Terms

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

TypeValueUnit
Catheter Gauge20French

Sterilization Methods

Method

Contacts

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

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00801741231001PureWickPW300PW3002026-02-06
00801741231018PureWickPW300CASEPW300CASE2026-02-06
10801741121941Bard® Robinson Catheter003708000370802016-07-23
10801741121965Bard® Robinson Catheter003712000371202016-07-23
10801741121972Bard® Robinson Catheter003714000371402016-07-23
10801741121989Bard® Robinson Catheter003716000371602016-07-23
10801741121996Bard® Robinson Catheter003718000371802016-07-23
10801741122016Bard® Robinson Catheter003722000372202016-07-23
10801741122023Bard® Robinson Catheter003724000372402016-07-23
10801741122030Bard® Robinson Catheter003726000372602016-07-23
10801741122047Bard® Robinson Catheter003728000372802016-07-23
10801741122061Bard® Robinson Catheter003732000373202016-07-23
10801741122078Bard® Robinson Catheter003734000373402016-07-23
10801741122092Bard® Robinson Catheter003736000373602016-07-23
10801741122108Bard® Robinson Catheter003738000373802016-07-23
10801741122115Bard® Robinson Catheter003740000374002016-07-23
10801741122122Bard® Robinson Catheter003742000374202016-07-23
10801741122139Bard® Robinson Catheter003744000374402016-07-23
10801741122146Bard® Robinson Catheter003746000374602016-07-23
10801741122153Bard® Robinson Catheter003748000374802016-07-23

Other Devices Sharing Product Codes

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10801741218832SureStep Foley Tray SystemC. R. Bard, Inc.EZC2024-05-13
10801741171663BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171677BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171684BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171691BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171707BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171717BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171724BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171731BardiaC. R. Bard, Inc.EZC2023-08-21
10801741171748BardiaC. R. Bard, Inc.EZC2023-08-21
20801741171752BardiaC. R. Bard, Inc.EZC2023-08-21
10801741218795SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
10801741218801SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
10801741218825SureStep Foley Tray SystemC. R. Bard, Inc.EZC2022-03-23
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10801741147477SureStep Foley Tray System with Bardex Lubricath Foley CatheterC. R. Bard, Inc.EZC2019-05-23
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00852141007208OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007215OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007246OneCathCOMPACTCATH, INC.EZC2018-09-12
00852141007338OneCathCOMPACTCATH, INC.EZC2018-09-12
44026704031816RUSCHTELEFLEX INCORPORATEDEZC2016-09-16
24026704031829RUSCHTELEFLEX INCORPORATEDEZC2016-09-16