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 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
Feb 12, 2010
COMFORTGEL NASAL MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
150d
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
Sep 10, 2009
COMFORT TWIN NASAL MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
80d
Cleared
Sep 03, 2009
COMFORT TWIN NASAL MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
142d
Cleared
Aug 03, 2009
QUATTRO LT
Resmed, Ltd.
Anesthesiology
105d
Cleared
Aug 03, 2009
REMSTAR AUTO A-FLEX
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
90d
Cleared
Jul 01, 2009
MINIME PEDIATRIC MASK
Sleepnet Corporation
Anesthesiology
90d
Cleared
May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
29d
Cleared
May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
Respironics, Inc.
Anesthesiology
28d
Cleared
May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
95d
Cleared
May 06, 2009
MIRAGE ECHO
ResMed Corp
Anesthesiology
70d
Cleared
Apr 22, 2009
APEX MEDICAL XT AUTO CPAP 9S-005200
Apex Medical Corp.
Anesthesiology
133d
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 30, 2009
REVOLUTIONFULL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology
123d
Cleared
Jan 13, 2009
VPAP AUTO WITH HUMIDAIRE 3I
Resmed, Ltd.
Anesthesiology
127d
Cleared
Jan 02, 2009
S8 ADVANCE
Resmed, Ltd.
Anesthesiology
88d
Cleared
Jan 02, 2009
RESSCAN-PRO
Resmed, Ltd.
Anesthesiology
88d