21 CFR 864.9100 — Container, Empty, For Collection & Processing Of Blood & Blood Components

Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9100

Identification

An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components216
Innolitics

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