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 04, 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
Respironics, Inc.
Anesthesiology
175d
Cleared
Feb 19, 2004
C2 NASAL MASK
Respironics, Inc.
Anesthesiology
79d
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
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
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
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
Jun 19, 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
Respironics, Inc.
Anesthesiology
13d
Cleared
May 22, 2002
ORION NASAL CPAP SYSTEM
Bird Products Corp.
Anesthesiology
77d
Cleared
Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
Respironics, Inc.
Anesthesiology
174d
Cleared
Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
Respironics, Inc.
Anesthesiology
24d
Cleared
Jun 25, 2001
ORACLE ORAL MASK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
189d
Cleared
Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
Respironics, Inc.
Anesthesiology
59d