Cord Blood Processing System And Storage Container

OAO · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.9900

Classification

FDA Product Code: OAO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.9900
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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 used as a functionally closed processing system by cord blood establishments. This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown