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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask; Numa Full Face Mask (BMC-FM2) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)); Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2); Viva Nasal Mask (Model: NM4) (Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2))
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
Premarket Submission Number: K163464
Owner/Operator: React Health
Owner/Operator Number: 10040143
Establishment Operations: Repackager/Relabeler
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