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 08, 2004
MIRAGE SWIFT
Resmed, Ltd.
Anesthesiology
35d
Cleared
Sep 10, 2004
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
Suiter Enterprises, Inc.
Anesthesiology
17d
Cleared
Sep 08, 2004
AURA CPAP PATIENT INTERFACE
Aeiomed, Inc.
Anesthesiology
33d
Cleared
Aug 31, 2004
HC604 CPAP HUMIDIFIER
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
48d
Cleared
Jul 30, 2004
APEX MEDICAL CPAP MODEL 9S-003
Apex Medical Corp.
Anesthesiology
23d
Cleared
Jul 22, 2004
GOODKNIGHT 425, MODELM-114500-00
Mallinckrodt Developpement France
Anesthesiology
16d
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
VENTLAB NASAL CPAP CANNULA
Ventlab Corp.
Anesthesiology
73d
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
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
ResMed Corp
Anesthesiology
363d
Cleared
Mar 10, 2004
RESMED S8 PRIME CPAP SYSTEM
Resmed, Ltd.
Anesthesiology
91d
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
Feb 13, 2004
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Sensor Medics Corp.
Anesthesiology
253d
Cleared
Feb 04, 2004
APEX MEDICAL CPAP RT 21XX
Apex Medical Corp.
Anesthesiology
544d