Bardex® I.C. 5cc/mL Balloon Foley Catheter
Bardex® I.C. Foley Catheter - 0165SI28
Device Description
A flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 28 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MJC
Device Name: Catheter, Urological (Antimicrobial) And Accessories
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.5130
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 10801741016810
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741016813
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741016813
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A