FDA.reportPublic FDA data

Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter

Primary DI
10801741019699
Brand
Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter
Company
C. R. Bard, Inc.
Model
304714A
Catalog number
304714A
Device description
Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter
Published
2016-07-26
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
MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJCCatheter, Urological (Antimicrobial) And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741019699PackageGS110In Commercial Distribution
00801741019692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101969910801741019699
00801741019692008017410196928017410196920801741019692

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 Gauge14French

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
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
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16925816600019Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600026Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600033Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600040Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600057Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600064Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600071Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600088Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600095Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600101Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600118Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600125Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600132Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600149Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600156Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600163Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600170Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600187Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600194Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600200Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600217Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600224Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600231Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16925816600248Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881122634Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881122641Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881122658Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881122665Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881122672Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31
16936881149426Latex Foley CatheterWell Lead Medical Co.,LtdMJC2024-05-31