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
Feb 27, 2013
QUATTRO AIR
Resmed, Ltd.
Anesthesiology
63d
Cleared
Feb 22, 2013
ZI BLOWER
Deshum Medical
Anesthesiology
291d
Cleared
Dec 06, 2012
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
Apex Medical Corp.
Anesthesiology
504d
Cleared
Nov 30, 2012
HARD SHELL VENTED NASAL MASK
Sleepnet Corporation
Anesthesiology
212d
Cleared
Nov 05, 2012
MINIME 2 NASAL MASK
Sleepnet Corporation
Anesthesiology
151d
Cleared
Nov 01, 2012
TAP PAP NASAL PILLOW MASK
Airway Management, Inc.
Anesthesiology
90d
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
Oct 02, 2012
ESON NASAL MASK
Fisher & Paykel Healthcare Limited
Anesthesiology
124d
Cleared
Jul 27, 2012
MOJO, VERASEAL
Sleepnet Corporation
Anesthesiology
163d
Cleared
Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
144d
Cleared
Jul 16, 2012
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
Hsiner Company
Anesthesiology
111d
Cleared
Jul 02, 2012
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
Curative Medical, Inc.
Anesthesiology
153d
Cleared
May 25, 2012
VPAP ADAPT
ResMed Corp
Anesthesiology
155d
Cleared
May 16, 2012
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
Apex Medical Corp.
Anesthesiology
133d
Cleared
Apr 27, 2012
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
3B Products, Inc.
Anesthesiology
420d
Cleared
Apr 24, 2012
SLEEPWEAVER ELAN NASAL CPAP MASK
Circadiance, LLC
Anesthesiology
42d
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
Feb 23, 2012
PILAIRO NASAL PILLOWS MASK
Fisher & Paykel Healthcare Limited
Anesthesiology
51d
Cleared
Feb 16, 2012
3B WILLOW
3B Products, LLC
Anesthesiology
192d
Cleared
Jan 06, 2012
MIRAGE QUATTRO
Resmed, Ltd.
Anesthesiology
74d
Cleared
Dec 16, 2011
REMSTAR AUTO A-FLEX HT
Respironics, Inc.
Anesthesiology
60d