Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
QYC · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.9115
Classification
FDA Product Code
QYC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.9115
Review panel
HE
Medical specialty
Hematology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.