FDA.reportPublic FDA data

Bardex® All-Silicone Foley Catheter

Primary DI
10801741029834
Brand
Bardex® All-Silicone Foley Catheter
Company
C. R. Bard, Inc.
Model
166822
Catalog number
166822
Device description
Bardex® All-Silicone Foley Catheter 30cc Balloon
Published
2016-05-31
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
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741029834PackageGS112In Commercial Distribution
00801741029837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174102983410801741029834
00801741029837008017410298378017410298370801741029837

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 Gauge22French

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
false
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
10610075097439OnliHOLLISTER INCORPORATEDGBM2026-02-01
10610075097446OnliHOLLISTER INCORPORATEDGBM2026-02-01
10610075097453OnliHOLLISTER INCORPORATEDGBM2026-02-01
20610075091922VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092585VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092592VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092608VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092615VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092622VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092639VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092646VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092653VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092660VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092677VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092684VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092691VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092707VaProHOLLISTER INCORPORATEDGBM2026-01-30
20192253058434DoverCardinal Health 200, LLCGBM2025-01-23
20192253058441DoverCardinal Health 200, LLCGBM2025-01-23
20192253058458DoverCardinal Health 200, LLCGBM2025-01-23
20192253058465DoverCardinal Health 200, LLCGBM2025-01-23
20192253058472DoverCardinal Health 200, LLCGBM2025-01-23
20192253058489DoverCardinal Health 200, LLCGBM2025-01-23
20192253058496DoverCardinal Health 200, LLCGBM2025-01-23
20192253058502DoverCardinal Health 200, LLCGBM2025-01-23
20192253058519DoverCardinal Health 200, LLCGBM2025-01-23
20192253058526DoverCardinal Health 200, LLCGBM2025-01-23
20192253058533DoverCardinal Health 200, LLCGBM2025-01-23
20192253058540DoverCardinal Health 200, LLCGBM2025-01-23
20610075104394InstantCathHOLLISTER INCORPORATEDGBM2024-07-09