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U.S. Department of Health and Human Services

Product Classification
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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 CodeQLE
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
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