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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Luna II CPAP and Auto CPAP System (Luna II QX CPAP and Auto CPAP System); Luna II/Auto
Classification Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Product Code: BZD
Device Class: 2
Regulation Number: 868.5905
Medical Specialty: Anesthesiology
Registered Establishment Name: 3B Medical Inc
Registered Establishment Number: 3009096682
Premarket Submission Number: K153387
Owner/Operator: React Health
Owner/Operator Number: 10040143
Establishment Operations: Complaint File Establishment
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