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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Disposable Adult/Ped Heated Active Circuit; Disposable Adult/Ped Heated Passive Circuit; Respironics Disposable Heated Wire Circuits
Classification Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
Product Code: BZE
Device Class: 2
Regulation Number: 868.5270
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K110398
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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