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
Jun 23, 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
Respironics, Inc.
Anesthesiology
70d
Cleared
May 02, 2006
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
Sleepnet Corporation
Anesthesiology
89d
Cleared
Feb 15, 2006
COMFORTLITE NASAL MASK
Respironics, Inc.
Anesthesiology
75d
Cleared
Feb 03, 2006
RES TRAXX DATA CENTER
Resmed, Ltd.
Anesthesiology
79d
Cleared
Nov 17, 2005
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
Cardinalhealth
Anesthesiology
189d
Cleared
Nov 04, 2005
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
Tiara Medical Systems, Inc.
Anesthesiology
142d
Cleared
Oct 20, 2005
M-SERIES PRO CPAP SYTEM
Respironics, Inc.
Anesthesiology
77d
Cleared
Aug 03, 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Cardinalhealth
Anesthesiology
106d
Cleared
Jul 15, 2005
RES TRAXX DATA CENTER
Resmed, Ltd.
Anesthesiology
56d
Cleared
Jul 08, 2005
IMASK, MODELS 100, 200 AND 300
Vital Signs Colorado, Inc.
Anesthesiology
25d
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
PIONEER U121 SERIES CPAP
Merits Health Products Co., Ltd.
Anesthesiology
308d
Cleared
May 10, 2005
RESSCAN
Resmed, Ltd.
Anesthesiology
43d
Cleared
May 04, 2005
IT NASAL MASK
Innomed Technologies
Anesthesiology
98d
Cleared
Mar 16, 2005
ULTRA MIRAGE II MASK
Resmed, Ltd.
Anesthesiology
30d
Cleared
Mar 09, 2005
AURA CPAP SYSTEM
Aeiomed, Inc.
Anesthesiology
135d
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
Feb 11, 2005
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
Sunrise Medical
Anesthesiology
77d
Cleared
Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
Respironics, Inc.
Anesthesiology
29d
Cleared
Jan 19, 2005
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
Tiara Medical Systems, Inc.
Anesthesiology
41d
Cleared
Jan 14, 2005
DEVILBISS NASAL CPAP MASK, 9354 SERIES
Sunrise Medical
Anesthesiology
126d