21 CFR 864.9195 — Device, Blood Mixing And Blood Weighing

Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9195

Identification

A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.

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
KSQDevice, Blood Mixing And Blood Weighing18
MYJDevice, Mixing And Weighing, Semi-Automated20
Innolitics

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