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QYCClass II

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

21 CFR 864.9115 / Hematology
FDA source (opens on fda.gov)

QYC is the FDA product code for Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions, a class II device type, regulated under 21 CFR 864.9115. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QYC
Device name
Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
FDA 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.
Regulation
21 CFR 864.9115
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code