Respiratory Accessory Microbial Reduction Device.
FDA product code QXQ · 2 cleared devices
- Regulation
- 21 CFR 880.6993
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2025-10-10 – 2026-04-29
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturers cleaning instructions.
SoClean 3+
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