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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2); Siesta full face mask; Siesta nasal mask (F5A; N5B)
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: K131901
Owner/Operator: React Health
Owner/Operator Number: 10040143
Establishment Operations: Repackager/Relabeler
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