21 CFR 864.9125 — System, Blood Collection, Vacuum-Assisted, Manual

Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9125

Identification

A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.

Classification Rationale

Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KSTSystem, Blood Collection, Vacuum-Assisted, Manual10
MYXSystem, Blood Collection, Vacuum-Assisted, Automated10
Innolitics

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