Device |
extracorporeal circuit and accessories for long term respiratory cariodpulmonary failure |
Definition |
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure for patient having cardiopulmonary failure during the declared public health emergency. |
Physical State |
n/a |
Technical Method |
n/a |
Target Area |
n/a |
Review Panel |
Cardiovascular |
Product Code | QOD |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Not Classified Reason
|
EUA - Emergency Use Authorization
|
Submission Type |
EUA - Emergency Use Authorization
|
Device Class |
Not Classified
|
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 |