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
Jun 06, 2011
TRUBLUE NASAL MASK
Respironics, Inc.
Anesthesiology
112d
Cleared
Mar 24, 2011
PERFORMAX TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
125d
Cleared
Mar 24, 2011
ZEST PETITE NASAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
87d
Cleared
Mar 18, 2011
S9 VPAP ADAPT WITH H5I
Resmed, Ltd.
Anesthesiology
190d
Cleared
Mar 16, 2011
MIRAGE MICRO
Resmed, Ltd.
Anesthesiology
28d
Cleared
Feb 17, 2011
GOLIFE NASAL MASK
Respironics, Inc.
Anesthesiology
45d
Cleared
Jan 05, 2011
S9 VPAP ST WITH H5I
Resmed, Ltd.
Anesthesiology
126d
Cleared
Dec 28, 2010
MIRAGE FX
Resmed, Ltd.
Anesthesiology
96d
Cleared
Dec 22, 2010
GOLIFE NASAL MASK
Respironics, Inc.
Anesthesiology
112d
Cleared
Dec 10, 2010
PIXI PEDIATRIC MASK
Resmed, Ltd.
Anesthesiology
126d
Cleared
Oct 08, 2010
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
277d
Cleared
Jun 09, 2010
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
Resmed, Ltd.
Anesthesiology
83d
Cleared
Apr 27, 2010
F&P ICON SERIES CPAP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
118d
Cleared
Feb 26, 2010
EASYCARE ONLINE
Resmed, Ltd.
Anesthesiology
88d
Cleared
Oct 02, 2009
EASYCARE TX, TX LINK
Resmed, Ltd.
Anesthesiology
88d
Cleared
Sep 28, 2009
S8 ASPEN WITH H4I PLUS
Resmed, Ltd.
Anesthesiology
90d
Cleared
Aug 03, 2009
QUATTRO LT
Resmed, Ltd.
Anesthesiology
105d
Cleared
May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
Respironics, Inc.
Anesthesiology
28d
Cleared
Apr 13, 2009
SWIFT FX
Resmed, Ltd.
Anesthesiology
70d
Cleared
Mar 25, 2009
COMFORTLITE NASAL MASK
Respironics, Inc.
Anesthesiology
202d
Cleared
Mar 20, 2009
RES TRAXX ONLINE, MODEL: R14
Resmed, Ltd.
Anesthesiology
88d
Cleared
Mar 16, 2009
ZEST NASAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
83d
Cleared
Jan 13, 2009
VPAP AUTO WITH HUMIDAIRE 3I
Resmed, Ltd.
Anesthesiology
127d
Cleared
Jan 02, 2009
S8 ADVANCE
Resmed, Ltd.
Anesthesiology
88d