21 CFR 864.9900 — Cord Blood Processing System And Storage Container
Hematology (HE) · Part 864 Subpart K—Products Used In Establishments That Manufacture HCT/Ps · § 864.9900
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OAO | Cord Blood Processing System And Storage Container | 2 | 0 | |
| OOF | Cryogenic Cord Blood Storage Container | 2 | 0 |
Special Controls
OAO — Cord Blood Processing System And Storage Container
*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).
eCFR
OAO — Cord Blood Processing System And Storage Container
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).
Ecfr Llm
OOF — Cryogenic Cord Blood Storage Container
*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).
eCFR
