Device |
container system for the processing and storage of red blood cell components under reduced oxygen conditions |
Regulation Description |
Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. |
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. |
Physical State |
Assembly of two components the Oxygen Reduction Bag (ORB) and the Storage Bag (HSB) |
Technical Method |
Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. |
Target Area |
Human clinical specimens |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | QYC |
Premarket Review |
CBER Division
(CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.9115
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |