PXM · Vomitus Clean-Up Kit
General Hospital · 21 CFR 880.6890 · Class 1
Overview
| Product Code | PXM |
|---|---|
| Device Name | Vomitus Clean-Up Kit |
| Regulation | 21 CFR 880.6890 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
