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Protective Barrier Enclosure With Negative Pressure

Protective Barrier Enclosure With Negative Pressure is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Protective Barrier Enclosure With Negative Pressure
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QLE

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Class N

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

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.