Device |
decontamination systems for n95 respirators |
Definition |
Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency. |
Physical State |
Sterilization or disinfection system |
Technical Method |
Sterilization or disinfection |
Target Area |
Previously used N95 or N95-equivalent respirators |
Review Panel |
General Hospital |
Product Code | QKY |
Premarket Review |
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
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 |