---
kind: "section"
citation: "21 C.F.R. § 864.9125"
title: "21"
number: "864.9125"
heading: "Vacuum-assisted blood collection system."
url: "https://uscodex.org/cfr/21/864.9125"
---

# §864.9125. Vacuum-assisted blood collection system.

- (a) **Identification.** A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
- (b) **Classification.** Class I (general controls). The manual device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

### Authority

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

### Amendments

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]