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
Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
107d
Cleared
Dec 04, 2003
MIRAGE ACTIVA MASK
Resmed, Ltd.
Anesthesiology
73d
Cleared
Dec 01, 2003
MULTI-STRAP FULL FACE MASK
Engineered Medical Systems
Anesthesiology
395d
Cleared
Oct 24, 2003
NASAL JACKS MASK
Resmed, Ltd.
Anesthesiology
79d
Cleared
Oct 16, 2003
AUTOSET SPIRIT SYSTEM
Resmed, Ltd.
Anesthesiology
65d
Cleared
Oct 15, 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
Vital Signs, Inc.
Anesthesiology
201d
Cleared
Sep 09, 2003
ARABELLA NCPAP MASKS
Hamilton Medical AG
Anesthesiology
200d
Cleared
Aug 25, 2003
LYRA NASAL MASK
Sensor Medics Corp.
Anesthesiology
68d
Cleared
Aug 19, 2003
MIRAGE VISTA MASK
Resmed, Ltd.
Anesthesiology
139d
Cleared
Aug 15, 2003
VPAP III
Resmed, Ltd.
Anesthesiology
151d
Cleared
Jul 02, 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
Resmed, Ltd.
Anesthesiology
194d
Cleared
Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
Respironics, Inc.
Anesthesiology
47d
Cleared
Jun 12, 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
232d
Cleared
Jun 12, 2003
SINGLE USE ORAL MASK, MODEL HC455A
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
224d
Cleared
Apr 09, 2003
MIRAGE ACTIVA MASK
Resmed, Ltd.
Anesthesiology
27d
Cleared
Feb 11, 2003
TWLIGHT, MODEL ISP 9600
Invacare Corp.
Anesthesiology
187d
Cleared
Jan 24, 2003
PEGASUS NASAL CPAP SYSTEM
Sensor Medics Corp.
Anesthesiology
203d
Cleared
Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
Resmed, Ltd.
Anesthesiology
58d
Cleared
Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
Resmed, Ltd.
Anesthesiology
56d
Cleared
Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
Resmed, Ltd.
Anesthesiology
55d
Cleared
Jul 16, 2002
AUTOSET SPIRIT CPAP SYSTEM
ResMed Corp
Anesthesiology
238d
Cleared
Jul 08, 2002
S7 ELITE CP AP SYSTEM
ResMed Corp
Anesthesiology
224d
Cleared
Jul 02, 2002
IQ NASAL MASK, MODEL 50160 REV. D
Sleepnet Corporation
Anesthesiology
53d
Cleared
Jun 19, 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
Respironics, Inc.
Anesthesiology
13d