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
Mar 28, 1997
NASALFLAIR
Airways Ltd., Inc.
Anesthesiology
702d
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
Oct 23, 1996
DPAP STEALTH SLEEPNET MODEL NUMBER 84000
Sleepnet Corporation
Anesthesiology
103d
Cleared
Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
Respironics, Inc.
Anesthesiology
406d
Cleared
Aug 15, 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
Respironics, Inc.
Anesthesiology
90d
Cleared
Aug 01, 1996
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
Resmed, Ltd.
Anesthesiology
85d
Cleared
Jul 29, 1996
NITELIFE BI-LEVEL CPAP
Airsep Corp.
Anesthesiology
755d
Cleared
Jul 18, 1996
SOLO CPAP SYSTEM
Respironics, Inc.
Anesthesiology
83d
Cleared
Jul 02, 1996
RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM
Rescare , Ltd.
Anesthesiology
405d
Cleared
Jun 26, 1996
MAESTRO CLINICAL REMOTE CONTROL
Respironics, Inc.
Anesthesiology
268d
Cleared
Jun 13, 1996
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
Sleepnet Corporation
Anesthesiology
310d
Cleared
May 28, 1996
SULLIVAN NOSE & MOUTH MASK SYSTEM
Rescare , Ltd.
Anesthesiology
364d
Cleared
May 09, 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
Puritan Bennett Corp.
Anesthesiology
94d
Cleared
May 07, 1996
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Nidek Medical Products, Inc.
Anesthesiology
315d
Cleared
Feb 08, 1996
MODEL #7354
Devilbiss Health Care, Inc.
Anesthesiology
349d
Cleared
Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
Respironics, Inc.
Anesthesiology
422d
Cleared
Jan 31, 1996
MODEL 7355
Devilbiss Health Care, Inc.
Anesthesiology
246d
Cleared
Jan 31, 1996
GEL MASK
Respironics, Inc.
Anesthesiology
146d
Cleared
Jan 30, 1996
ARIA CPAP SYSTEM
Respironics, Inc.
Anesthesiology
266d
Cleared
Nov 13, 1995
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
Puritan Bennett Corp.
Anesthesiology
181d
Cleared
Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
Healthdyne, Inc.
Anesthesiology
237d
Cleared
Mar 29, 1995
SPECTRUM(TM) MASK
Respironics, Inc.
Anesthesiology
464d