Bardex® I.C. Complete Care® Foley Tray
Bardex® I.C. Complete Care® Foley Tray - 320016A
Device Description
A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 16 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: 10801741019415
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741019418
Package Quantity: 10
Package Discontinue Date: 9/3/2021 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CA
Device Id: 00801741019418
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