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
Dec 15, 1986
BIRD NIGHTBIRD NASAL CPAP SYSTEM
Bird Products Corp.
Anesthesiology
82d
Cleared
Nov 14, 1986
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
Life Design Systems, Inc.
Anesthesiology
140d
Cleared
Jun 05, 1986
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
Respiratory Care, Inc.
Anesthesiology
41d
Cleared
May 09, 1986
MEDICOMP CPAP NASAL CANNULA
Medicomp, Inc.
Anesthesiology
32d
Cleared
Sep 06, 1985
PATIENT BREATHING CIRCUIT
Infrasonics Corp.
Anesthesiology
17d
Cleared
Jul 29, 1985
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
Puritan Bennett Corp.
Anesthesiology
27d
Cleared
Jul 26, 1984
INFANT NASAL CANNULAE ASSEMBLY
Ackrad Laboratories
Anesthesiology
87d
Cleared
Jan 28, 1983
CPAP INFANT NASAL CANNULAE SET
Ackrad Laboratories
Anesthesiology
30d
Cleared
Jun 02, 1981
ARGYLE CPAP NASAL CANNULA
Sherwood Medical Co.
Anesthesiology
14d
Cleared
Jan 24, 1980
NOVAMETRIX CPAP NASAL CANNULA
Novametrix Medical Systems, Inc.
Anesthesiology
24d