Product code QLE
- Device name
- Protective Barrier Enclosure With Negative Pressure
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset