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
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
Nov 02, 2001
MINIME NASAL MASK, MODEL P/N 50220
Sleepnet Corporation
Anesthesiology
29d
Cleared
Jul 24, 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
Sensor Medics Corp.
Anesthesiology
25d
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
May 04, 2001
REMREST
Medical Industries America, Inc.
Anesthesiology
241d
Cleared
Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
Respironics, Inc.
Anesthesiology
59d
Cleared
Oct 23, 2000
AERO-CLICK
Map Medizintechnik Fur Arzt Und Patient GmbH
Anesthesiology
403d
Cleared
Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
Respironics, Inc.
Anesthesiology
190d
Cleared
Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
Respironics, Inc.
Anesthesiology
28d
Cleared
Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
Puritan Bennett Corp.
Anesthesiology
68d
Cleared
Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
Vital Signs, Inc.
Anesthesiology
77d
Cleared
Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
Respironics, Inc.
Anesthesiology
86d
Cleared
May 26, 2000
SWIVEL ELBOW
Engineered Medical Systems
Anesthesiology
123d
Cleared
May 12, 2000
AIRPILOTMASK, MODEL TMS-900
Tiara Medical Systems, Inc.
Anesthesiology
318d
Cleared
Mar 07, 2000
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
Nellcor Puritan Bennett France Dvpt.
Anesthesiology
137d
Cleared
Jan 11, 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
Bird Products Corp.
Anesthesiology
302d
Cleared
Dec 01, 1999
CPAP/PRO CPAP INTERFACE
Stevenson Industries, Inc.
Anesthesiology
138d
Cleared
Nov 26, 1999
NASAL AIRE
Breathing Technologies Corp.
Anesthesiology
270d
Cleared
Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
Respironics, Inc.
Anesthesiology
68d
Cleared
Oct 27, 1999
IQ NASAL MASK, MODEL P/N 50160
Sleepnet Corporation
Anesthesiology
27d
Cleared
Oct 27, 1999
ARIA LX CPAP SYSTEM
Respironics, Inc.
Anesthesiology
23d
Cleared
Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
Respironics, Inc.
Anesthesiology
15d