Product code QYC
- Device name
- Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9115
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset