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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: butterflyBVM
Classification Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Product Code: BTM
Device Class: 2
Regulation Number: 868.5915
Medical Specialty: Anesthesiology
Registered Establishment Name: 316 CONTRACT MANUFACTURING LLC
Registered Establishment Number: 3038772438
Premarket Submission Number: K243861
Owner/Operator: 316 Contract Manufacturing LLC
Owner/Operator Number: 10093596
Establishment Operations: Contract Manufacturer
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