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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: A30 Heated Humidifier; BiPAP A30 Ventilatory Support System; BiPAP V30 Auto; DirectView Data Management System; Universal Battery Pack (UBP2)
Classification Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Product Code: MNS
Device Class: 2
Regulation Number: 868.5895
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K113053
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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