---
kind: "section"
citation: "21 C.F.R. § 868.5795"
title: "21"
number: "868.5795"
heading: "Tracheal tube cleaning brush."
url: "https://uscodex.org/cfr/21/868.5795"
---

# §868.5795. Tracheal tube cleaning brush.

- (a) **Identification.** A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 868.9](/cfr/21/868.9.md). If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025]