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, 1995
PURITAN-BENNETT COMPANION 320 I/E
Puritan Bennett Corp.
Anesthesiology
508d
Cleared
Nov 28, 1994
POSITIVE AIRWAY PRESSURE SYSTEM
Innovative Medical Systems, Inc.
Anesthesiology
516d
Cleared
Nov 10, 1994
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
Devilbiss Health Care, Inc.
Anesthesiology
332d
Cleared
Feb 17, 1994
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
Portable Power Systems, Inc.
Anesthesiology
330d
Cleared
Sep 14, 1993
NASAL/ORAL MASK
Respironics, Inc.
Anesthesiology
313d
Cleared
Jul 21, 1993
TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
240d
Cleared
Apr 09, 1993
318A RESPIRATORY SUPPORT SYSTEM
Puritan Bennett Corp.
Anesthesiology
263d
Cleared
Dec 07, 1992
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
Respironics, Inc.
Anesthesiology
313d
Cleared
Oct 18, 1991
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
Vital Signs, Inc.
Anesthesiology
198d
Cleared
Sep 23, 1991
LIFECARE CPAP-100
Lifecare Services, Inc.
Anesthesiology
126d
Cleared
Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
Respironics, Inc.
Anesthesiology
105d
Cleared
Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
Salter Labs
Anesthesiology
57d
Cleared
Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
Ackrad Laboratories
Anesthesiology
63d
Cleared
May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
Medtronic Vascular
Anesthesiology
161d
Cleared
May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
Puritan Bennett Corp.
Anesthesiology
117d
Cleared
May 01, 1991
SLEEPER MASK SYSTEM
Devilbiss Health Care, Inc.
Anesthesiology
219d
Cleared
Apr 23, 1991
SLEEPAP
Medical Industries America, Inc.
Anesthesiology
131d
Cleared
Mar 26, 1991
DEVILBISS MODEL 7352 SERIES
Devilbiss Health Care, Inc.
Anesthesiology
155d
Cleared
Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
Respironics, Inc.
Anesthesiology
50d
Cleared
Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
Ackrad Laboratories
Anesthesiology
83d
Cleared
May 14, 1987
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
Holter-Hausner Intl.
Anesthesiology
38d
Cleared
Apr 21, 1987
C.P.A.P. NASAL CANNULA
Hudson Oxygen Therapy Sales Co.
Anesthesiology
28d
Cleared
Dec 15, 1986
BIRD NIGHTBIRD NASAL CPAP SYSTEM
Bird Products Corp.
Anesthesiology
82d
Cleared
Nov 14, 1986
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
Life Design Systems, Inc.
Anesthesiology
140d