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 18, 1999
OPAP
Opap, Inc.
Anesthesiology
133d
Cleared
Aug 13, 1999
INFANT FLOW SYSTEM
Sensor Medics Corp.
Anesthesiology
63d
Cleared
Aug 13, 1999
MONARCH II MINI MASK
Respironics, Inc.
Anesthesiology
31d
Cleared
Jul 26, 1999
SULLIVAN AUTOSET NASAL CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
234d
Cleared
May 28, 1999
REUSABLE CONTOUR II NASAL MASK
Respironics, Inc.
Anesthesiology
15d
Cleared
Apr 14, 1999
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
Nellcor Puritan Bennett France Dvpt.
Anesthesiology
8d
Cleared
Feb 24, 1999
INFANT FLOW NCPAP MASKS
Sensor Medics Corp.
Anesthesiology
89d
Cleared
Jan 27, 1999
INVACARE CPAP
Invacare Corp.
Anesthesiology
216d
Cleared
Nov 17, 1998
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Nidek Medical Products, Inc.
Anesthesiology
278d
Cleared
Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
Resmed, Ltd.
Anesthesiology
88d
Cleared
Oct 14, 1998
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
W. Keith Thornton, D.D.S.
Anesthesiology
149d
Cleared
Sep 01, 1998
SULLIVAN AUTOSET
Resmed, Ltd.
Anesthesiology
189d
Cleared
Aug 04, 1998
NASAL INTERFACE MODEL 7910
Healthdyne Technologies, Inc.
Anesthesiology
252d
Cleared
Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
Nellcor Puritan Bennett, Inc.
Anesthesiology
174d
Cleared
Jul 10, 1998
CPAP HUMIDIFIER (HC 200)
Fisher & Paykel Electronics , Ltd.
Anesthesiology
322d
Cleared
Jun 29, 1998
MODEL 7410 VOYAGER
Healthdyne Technologies, Inc.
Anesthesiology
181d
Cleared
Jan 30, 1998
INFANT FLOW SYSTEM
Sensor Medics Corp.
Anesthesiology
74d
Cleared
Jan 28, 1998
EMS NASAL CPAP MASK
Engineered Medical Systems
Anesthesiology
201d
Cleared
Jul 31, 1997
TMS COMFORT SERIES NASAL CPAP MASK
Tiara Medical Systems, Inc.
Anesthesiology
293d
Cleared
Jun 20, 1997
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
109d
Cleared
Jun 18, 1997
MORPHEE PLUS ALPHA
Nellcor Puritan Bennett, Inc.
Anesthesiology
254d
Cleared
May 09, 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
87d
Cleared
Apr 18, 1997
QUARTET CLINICAL SYSTEM
Respironics, Inc.
Anesthesiology
212d
Cleared
Apr 16, 1997
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
Healthdyne Technologies, Inc.
Anesthesiology
90d