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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 864.9115
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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