đź“‹ FDA Reference
bever unocated coated paediatric male female nelaton-tip tiemann-tip intermittent catheter
Hangzhou Bever Medical Devices
Summary: The Bever Unocated Coated Pediatric Catheter is a medical device used for intermittent catheterization in pediatric patients. It is designed for both male and female use, with nelaton and tiemann tips for ease of insertion.
FDA Clearance Information
Pathway
510K
Number
K111405 ↗
Decision Date
February 13, 2012
Product Code
GBM
Device Class
Class 2
Evidence
0 studies
The Bever Unocated Coated Pediatric Catheter was cleared through the FDA 510k pathway on February 13, 2012. Manufactured by Hangzhou Bever Medical Devices, it is classified as a Class 2 device under product code GBM.
What It Is
This device is an intermittent catheter designed for pediatric patients, available in both nelaton and tiemann tips to facilitate easier insertion. The catheter is coated to reduce friction and discomfort during use. It is intended for temporary urinary drainage and is suitable for both male and female patients.
Clinical Applications
The catheter is commonly used in pediatric urology for patients who require intermittent catheterization due to urinary retention or neurogenic bladder. It is also used in hospital settings and outpatient clinics for children with conditions that affect normal urination. Pediatricians and urologists are the primary users of this device.
Indications for Use
The catheter is indicated for use in pediatric patients who need intermittent catheterization to manage urinary retention or other bladder dysfunctions. It is suitable for both male and female patients, providing a solution for those who cannot empty their bladder naturally.
Practical Considerations
The catheter comes in various sizes to accommodate different pediatric age groups. It is important to select the appropriate size for each patient to ensure comfort and effectiveness. The coated surface helps minimize urethral trauma during insertion.
Frequently Asked Questions
What is the Bever Unocated Coated Pediatric Catheter used for?
It is used for intermittent catheterization in pediatric patients to manage urinary retention or bladder dysfunction.
What specialties typically use this device?
Pediatricians and urologists commonly use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The catheter is indicated for use in pediatric patients requiring intermittent catheterization for urinary retention or bladder dysfunction.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.