FDA Product Code BZD: Ventilator, Non-continuous (respirator)
FDA product code BZD covers non-continuous ventilators, also known as intermittent positive pressure breathing (IPPB) devices and home respiratory support equipment.
Unlike continuous ventilators, these devices deliver assisted breaths only when triggered by the patient or on an intermittent schedule. They are used for the treatment of chronic respiratory conditions, post-operative respiratory therapy, and as backup support for patients with mild ventilatory insufficiency.
BZD devices are Class II medical devices, regulated under 21 CFR 868.5905 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Respironics, Inc., Sleepnet Corporation and ResMed Corp.
460
Total
460
Cleared
155d
Avg days
1977
Since
460 devices
Cleared
May 17, 2019
WiZARD 310/320 Series CPAP Mask
Apex Medical Corp.
Anesthesiology
255d
Cleared
May 07, 2019
Moore Park Mask
Resmed, Ltd.
Anesthesiology
140d
Cleared
Jan 04, 2019
Care Orchestrator
Respironics, Inc.
Anesthesiology
259d
Cleared
Nov 30, 2018
Transcend 365 miniCPAP System
Somnetics International, Inc.
Anesthesiology
290d
Cleared
Aug 08, 2018
F&P SleepStyle
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
310d
Cleared
Jun 15, 2018
Scone Mask
Resmed, Ltd.
Anesthesiology
109d
Cleared
Mar 30, 2018
Bleep DreamPort
Snapcpap
Anesthesiology
240d
Cleared
Jan 03, 2018
AirFit F20
Resmed, Ltd.
Anesthesiology
280d
Cleared
Sep 28, 2017
AirFit N20
Resmed, Ltd.
Anesthesiology
156d
Cleared
May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
Medtronic Vascular
Anesthesiology
161d