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
Oct 09, 2008
MODIFICATION TO MIRAGE MICRO
Resmed, Ltd.
Anesthesiology
150d
Cleared
Sep 12, 2008
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
228d
Cleared
Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
154d
Cleared
Apr 25, 2008
COMFORTGEL FULL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
126d
Cleared
Apr 08, 2008
S8 ESCAPE II
Resmed, Ltd.
Anesthesiology
88d
Cleared
Apr 01, 2008
VPAP ST
Resmed, Ltd.
Anesthesiology
74d
Cleared
Mar 20, 2008
SWIFT LT
Resmed, Ltd.
Anesthesiology
85d
Cleared
Jan 04, 2008
TXCONTROL
Resmed, Ltd.
Anesthesiology
109d
Cleared
Dec 27, 2007
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
Respironics, Inc.
Anesthesiology
64d
Cleared
Dec 19, 2007
PERFORMAX TOTAL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
96d
Cleared
Dec 13, 2007
MIRAGE MICRO
Resmed, Ltd.
Anesthesiology
57d
Cleared
Oct 10, 2007
MIRAGE MICRO
Resmed, Ltd.
Anesthesiology
100d
Cleared
Jul 13, 2007
RESTRAXX DATA CENTRE, MODEL R10
Resmed, Ltd.
Anesthesiology
116d
Cleared
Jul 10, 2007
VPAP AUTO WITH H3I
Resmed, Ltd.
Anesthesiology
74d
Cleared
May 04, 2007
APEX MEDICAL XT1 CPAP, MODEL 9S-005
Apex Medical Corp.
Anesthesiology
60d
Cleared
Apr 30, 2007
TWILIGHT FULL FACE MASK
Invacare Corp.
Anesthesiology
87d
Cleared
Mar 09, 2007
REMSTAR AFLEX CPAP SYSTEM
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
73d
Cleared
Feb 02, 2007
MIRAGE LIBERTY FULL FACE MASK
Resmed, Ltd.
Anesthesiology
123d
Cleared
Feb 02, 2007
MIRAGE QUATTRO FULL FACE MASK
Resmed, Ltd.
Anesthesiology
113d
Cleared
Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
80d
Cleared
Sep 08, 2006
VPAP MALIBU WITH H2I
Resmed, Ltd.
Anesthesiology
32d
Cleared
Sep 05, 2006
INVACARE'S TWILIGHT II NASAL MASKS
Invacare Corp.
Anesthesiology
64d
Cleared
Aug 29, 2006
FLEXIFIT HC432 FULL FACE MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
118d
Cleared
Jul 20, 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
Resmed, Ltd.
Anesthesiology
80d