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
Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
Respironics, Inc.
Anesthesiology
190d
Cleared
Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
Respironics, Inc.
Anesthesiology
28d
Cleared
Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
Puritan Bennett Corp.
Anesthesiology
68d
Cleared
Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
Vital Signs, Inc.
Anesthesiology
77d
Cleared
Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
Respironics, Inc.
Anesthesiology
86d
Cleared
Jan 11, 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
Bird Products Corp.
Anesthesiology
302d
Cleared
Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
68d
Cleared
Oct 27, 1999
ARIA LX CPAP SYSTEM
Respironics, Inc.
Anesthesiology
23d
Cleared
Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
Respironics, Inc.
Anesthesiology
15d
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
Jan 27, 1999
INVACARE CPAP
Invacare Corp.
Anesthesiology
216d
Cleared
Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
Resmed, Ltd.
Anesthesiology
88d
Cleared
Sep 01, 1998
SULLIVAN AUTOSET
Resmed, Ltd.
Anesthesiology
189d
Cleared
Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
Nellcor Puritan Bennett, Inc.
Anesthesiology
174d
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
Jan 30, 1997
BIPAP DUET SYSTEM
Respironics, Inc.
Anesthesiology
90d
Cleared
Dec 05, 1996
WHISPER SWIVEL II EXHALATION PORT
Respironics, Inc.
Anesthesiology
181d
Cleared
Nov 14, 1996
PRESSURE VALVE
Respironics, Inc.
Anesthesiology
87d
Cleared
Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
Respironics, Inc.
Anesthesiology
406d