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 Resmed, Ltd., Respironics, Inc. and Fisher &Paykel Healthcare , Ltd..
461
Total
461
Cleared
155d
Avg days
1977
Since
461 devices
Cleared
Jul 05, 2019
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
Sleepnet Corporation
Anesthesiology
148d
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
Sep 05, 2017
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
Bmc Medical., Ltd.
Anesthesiology
270d
Cleared
Mar 15, 2017
SleepWeaver 3D Nasal Mask
Circadiance, LLC
Anesthesiology
149d
Cleared
Jan 24, 2017
F&P InfoSmart
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
221d
Cleared
Jan 18, 2017
F&P Brevida™ Nasal Pillows Mask
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
243d
Cleared
Dec 15, 2016
Menai System
Resmed, Ltd.
Anesthesiology
265d
Cleared
Nov 17, 2016
AirFit N20
Resmed, Ltd.
Anesthesiology
122d
Cleared
Nov 10, 2016
iCodeConnect
3B Medical, Inc.
Anesthesiology
295d
Cleared
Sep 20, 2016
F&P Eson 2 Nasal Mask
Fisher & Paykel Healthcare Limited
Anesthesiology
288d
Cleared
Sep 09, 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
Resmed, Ltd.
Anesthesiology
169d
Cleared
Sep 08, 2016
Luna CPAP and Auto CPAP System
3B Medical, Inc.
Anesthesiology
290d
Cleared
May 13, 2016
AirFit F20
Resmed, Ltd.
Anesthesiology
151d
Cleared
May 02, 2016
AirFit N20
Resmed, Ltd.
Anesthesiology
133d
Cleared
Apr 15, 2016
Simple T Pediatric Nasal Mask
Respironics, Inc.
Anesthesiology
354d
Cleared
Apr 05, 2016
SleepWeaver Advance Pediatric Nasal CPAP Mask
Circadiance, LLC
Anesthesiology
288d