21 CFR 880.6886 — Foam Or Gel Chemical Sterilant/High Level Disinfectant
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6886
Identification
Tristel Duo ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumened ultrasound probes, including endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin. It generates chlorine dioxide foam from two precursor solutions (Base and Activator) dispensed via a pump mechanism. It is intended for use by qualified healthcare personnel at the point of care, requiring a 2-minute contact time at room temperature at or above the Minimum Recommended Concentration (MRC).
Classification Rationale
Class II (special controls). The device is a foam or gel chemical sterilant/high level disinfectant, regulated under 21 CFR 880.6886, which requires special controls in addition to general controls to provide reasonable assurance of safety and effectiveness.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant | 2 | 2 |
Special Controls
QWS — Foam Or Gel Chemical Sterilant/High Level Disinfectant
In combination with the general controls of the FD&C Act, the foam or gel chemical sterilant/high level disinfectant is subject to the following special controls:
De Novo Order DEN220041
