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
Jan 21, 2016
DeVilbiss DV6WM Wireless Modem
Devilbiss Healthcare, LLC
Anesthesiology
115d
Cleared
Jan 08, 2016
Sapphire
Respironics, Inc.
Anesthesiology
141d
Cleared
Sep 18, 2015
DeVilbiss Intellipap2/DeVilbiss BLUE
Devilbiss Healthcare, LLC
Anesthesiology
268d
Cleared
Sep 18, 2015
AF541 EE Full Face Mask
Respironics, Inc.
Anesthesiology
191d
Cleared
Sep 15, 2015
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Apex Medical Corp.
Anesthesiology
238d
Cleared
Aug 24, 2015
Skynector CPAP Mask
Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
Anesthesiology
160d
Cleared
Aug 05, 2015
CPAP Cannulaide
Salter Labs
Anesthesiology
224d
Cleared
Jul 21, 2015
Cloud9 System
Insleep Technologies, LLC
Anesthesiology
159d
Cleared
May 21, 2015
Darlinghurst Vented, Darlinghurst NV-AAV
Resmed, Ltd.
Anesthesiology
154d
Cleared
Apr 22, 2015
LUNA CPAP AND AUTO-CPAP SYSTEM
3B Medical, Inc.
Anesthesiology
295d
Cleared
Feb 10, 2015
TI NASAL MASK
Respironics, Inc.
Anesthesiology
300d
Cleared
Jan 16, 2015
REVOLUTION FULLFACE MASK
Respironics Inc. (Dba Philips Respironics)
Anesthesiology
316d
Cleared
Jan 09, 2015
Revolution Full Face Mask
Respironics, Inc.
Anesthesiology
120d
Cleared
Oct 20, 2014
SIMPLE T YOUTH NASAL MASK
Respironics, Inc.
Anesthesiology
250d
Cleared
Oct 17, 2014
Z1 CPAP SYSTEM
Human Design Medical, LLC
Anesthesiology
191d
Cleared
Oct 17, 2014
ADVANTAGE
Stevenson Industries, Inc.
Anesthesiology
165d
Cleared
Oct 06, 2014
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
Apex Medical Corp.
Anesthesiology
119d
Cleared
Aug 25, 2014
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
3B Medical, Inc.
Anesthesiology
257d
Cleared
Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
Devilbiss Healthcare, LLC
Anesthesiology
119d
Cleared
Jul 31, 2014
S9 GREENHILLS
Resmed, Ltd.
Anesthesiology
178d
Cleared
Jun 17, 2014
S9 WANDA VPAP ST
Resmed, Ltd.
Anesthesiology
146d
Cleared
Jun 09, 2014
AIRSOFT F15
Resmed, Ltd.
Anesthesiology
266d
Cleared
May 16, 2014
RESCAN
Resmed, Ltd.
Anesthesiology
127d
Cleared
May 12, 2014
S9 ELOUERA
ResMed Corp
Anesthesiology
116d