Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart K — Products Used In Establishments That Manufacture HCT/Ps](/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps) → [21 CFR 864.9900](/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps/864.9900) → OAO — Cord Blood Processing System And Storage Container

# OAO · Cord Blood Processing System And Storage Container

_Hematology · 21 CFR 864.9900 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps/OAO

## Overview

- **Product Code:** OAO
- **Device Name:** Cord Blood Processing System And Storage Container
- **Regulation:** [21 CFR 864.9900](/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps/864.9900)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” For the availability of this guidance document, see § 864.1(d).

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” For the availability of this guidance document, see § 864.1(d).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps/OAO](https://fda.innolitics.com/submissions/HE/subpart-k%E2%80%94products-used-in-establishments-that-manufacture-hct-ps/OAO)

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