🆕 FDA Approval: Tristel Duo ULT High-Level Disinfectant Foam

Approval Details:

• Product:  Tristel Duo ULT High-Level Disinfectant Foam
• FDA De Novo Number: DEN220041
• Status:  First FDA-approved High-Level Disinfectant (HLD) in foam and wipe form

Key Features:

• Active Ingredient: 320 ppm Chlorine Dioxide
• Application Method:
  • Manual use with DUO Wipes
  • Foam generated on-site, applied to probe surface
• Contact Time: 2 minutes at 20°C
• Intended Use:
  • Transvaginal probes
  • Transrectal probes
  • Skin surface ultrasound transducers

    

 Important Notes:

• Single-use only – do not reuse foam or wipes
• Contact time and efficacy validated through simulated use testing with ultrasound transducers
• Designed for manual high-level disinfection, ideal for environments where automated      systems are not available

Compliance & Practical Use:

• This innovation allows facilities to meet HLD requirements for semi-critical devices using a portable, easy-to-use format
• Ideal for OB/GYN clinics, radiology departments, and point-of-care ultrasound settings
• Supports workflow flexibility without sacrificing infection control standards

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Interested in Implementing/Auditing HLD Tool at Your Facility? 

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