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
Oct 20, 2005
M-SERIES PRO CPAP SYTEM
Respironics, Inc.
Anesthesiology
77d
Cleared
Jul 15, 2005
RES TRAXX DATA CENTER
Resmed, Ltd.
Anesthesiology
56d
Cleared
Jun 15, 2005
BIPAP AUTO
Respironics, Inc.
Anesthesiology
83d
Cleared
Jun 13, 2005
GOODKNIGHT 425ST
Nellcor Puritan Bennett, Inc.
Anesthesiology
152d
Cleared
May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
44d
Cleared
May 10, 2005
RESSCAN
Resmed, Ltd.
Anesthesiology
43d
Cleared
Mar 16, 2005
ULTRA MIRAGE II MASK
Resmed, Ltd.
Anesthesiology
30d
Cleared
Mar 04, 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
Salter Labs
Anesthesiology
400d
Cleared
Mar 01, 2005
RESMED MERIDIAN MASK
Resmed, Ltd.
Anesthesiology
36d
Cleared
Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
Respironics, Inc.
Anesthesiology
29d
Cleared
Oct 08, 2004
MIRAGE SWIFT
Resmed, Ltd.
Anesthesiology
35d
Cleared
Aug 31, 2004
HC604 CPAP HUMIDIFIER
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
48d
Cleared
Jul 15, 2004
RESMED HOSPITAL FULL FACE MASK
Resmed, Ltd.
Anesthesiology
56d
Cleared
Jul 01, 2004
RESMED S8 PIONEER CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
52d
Cleared
Jun 30, 2004
IMASK TM
Vital Signs, Inc.
Anesthesiology
44d
Cleared
Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
59d
Cleared
Jun 03, 2004
RESCONTROL II
Resmed, Ltd.
Anesthesiology
52d
Cleared
May 05, 2004
RESCAN
Resmed, Ltd.
Anesthesiology
128d
Cleared
May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
68d
Cleared
May 05, 2004
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
Respironics, Inc.
Anesthesiology
15d
Cleared
Apr 22, 2004
OXYGEN DIVERTER VALVE
Resmed, Ltd.
Anesthesiology
126d
Cleared
Apr 02, 2004
RESMED HOSPITAL NASAL MASK
Resmed, Ltd.
Anesthesiology
29d
Cleared
Mar 12, 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
Invacare Corp.
Anesthesiology
344d
Cleared
Mar 10, 2004
RESMED S8 PRIME CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
91d