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 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
Jan 13, 2014
S9 CRONULLA FOR HER
Resmed, Ltd.
Anesthesiology
146d
Cleared
Dec 20, 2013
AIRFIT N10
Resmed, Ltd.
Anesthesiology
95d
Cleared
Nov 20, 2013
BRONCHOSCOPY ELBOW
Respironics, Inc.
Anesthesiology
131d
Cleared
Oct 21, 2013
SWIFT AIR
Resmed, Ltd.
Anesthesiology
112d
Cleared
Oct 18, 2013
REMSTAR AUTO A-FLEX HT
Respironics, Inc.
Anesthesiology
112d
Cleared
May 21, 2013
REMSTAR SE
Respironics, Inc.
Anesthesiology
127d
Cleared
Mar 29, 2013
SWIFT FX NANO
Resmed, Ltd.
Anesthesiology
109d
Cleared
Mar 06, 2013
KANGAROO NASAL MASK
Respironics, Inc.
Anesthesiology
169d
Cleared
Feb 27, 2013
QUATTRO AIR
Resmed, Ltd.
Anesthesiology
63d
Cleared
Oct 23, 2012
GEO
Resmed, Ltd.
Anesthesiology
137d
Cleared
Oct 09, 2012
REMSTAR SE
Respironics, Inc.
Anesthesiology
29d
Cleared
Oct 05, 2012
SIMPLE T NASAL MASK
Respironics, Inc.
Anesthesiology
123d
Cleared
Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
144d
Cleared
Apr 20, 2012
EASYCARE TX SYSTEM (CONNEXUNS)
Resmed, Ltd.
Anesthesiology
120d
Cleared
Mar 30, 2012
SIMPLE T NASAL MASK
Respironics, Inc.
Anesthesiology
72d
Cleared
Jan 06, 2012
MIRAGE QUATTRO
Resmed, Ltd.
Anesthesiology
74d
Cleared
Dec 16, 2011
REMSTAR AUTO A-FLEX HT
Respironics, Inc.
Anesthesiology
60d
Cleared
Dec 07, 2011
SWIFT FX BELLA
Resmed, Ltd.
Anesthesiology
100d
Cleared
Nov 16, 2011
TASMAN
Resmed, Ltd.
Anesthesiology
89d
Cleared
Aug 19, 2011
INFOSEND GSM
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
197d