Cryogenic Cord Blood Storage Container

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

Classification

FDA Product Code: OOF
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

Intended as a final container for the cryopreservation and the storage of cord blood products. A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen.

Market data

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

Source

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