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
Dec 07, 2011
SWIFT FX BELLA
Resmed, Ltd.
Anesthesiology
100d
Cleared
Nov 22, 2011
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
Devilbiss Healthcare, LLC
Anesthesiology
112d
Cleared
Nov 16, 2011
SOYALA SILKGEL FULL FACE MASK
Weinmann Gerate Fur Medizin GmbH + Co. KG
Anesthesiology
111d
Cleared
Nov 16, 2011
TASMAN
Resmed, Ltd.
Anesthesiology
89d
Cleared
Oct 13, 2011
3B FLEX-LITE
3B Products, LLC
Anesthesiology
324d
Cleared
Oct 07, 2011
BABI PLUS INFANT NASAL CANNULA SYSTEM
A Plus Medical
Anesthesiology
231d
Cleared
Aug 19, 2011
INFOSEND GSM
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
197d
Cleared
Aug 01, 2011
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
A Plus Medical
Anesthesiology
172d
Cleared
Jul 12, 2011
EASYFIT SILKGEL NASAL MASK
Weinmann Gerate Fur Medizin GmbH + Co. KG
Anesthesiology
104d
Cleared
Jun 30, 2011
S8 ASPEN WITH H4I PLUS
ResMed Corp
Anesthesiology
69d
Cleared
Jun 06, 2011
TRUBLUE NASAL MASK
Respironics, Inc.
Anesthesiology
112d
Cleared
May 17, 2011
IQ VENTILATION NASAL MASK
Sleepnet Corporation
Anesthesiology
274d
Cleared
May 06, 2011
APEX MEDICAL WIZARD SERIES CPAP MASK
Apex Medical Corp.
Anesthesiology
191d
Cleared
Mar 30, 2011
NEOPAP SYSTEM
Childrens Medical Ventures, LLC
Anesthesiology
128d
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