Bardex® Pezzer Model Drain Proportionate Head
Bardex® Pezzer Model Drain - 064026
Device Description
A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 26 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FEW
Device Name: Catheter, Malecot
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: 876.5090
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 10801741030090
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741030093
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741030093
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