Device |
protective barrier enclosure with negative pressure |
Definition |
A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency. |
Physical State |
Protective Barrier Enclosure with Negative Pressure |
Technical Method |
Protective Barrier Enclosure with Negative Pressure |
Target Area |
Infection Control |
Review Panel |
General Hospital |
Product Code | QLE |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
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 |