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 Sleepnet Corporation, ResMed Corp and Respironics, Inc..
457
Total
457
Cleared
154d
Avg days
1977
Since
457 devices
Cleared
Mar 18, 2022
F&P Evora Full Face Mask
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
231d
Cleared
Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
Sleepnet Corporation
Anesthesiology
258d
Cleared
Aug 24, 2021
DreamWear Silicone Pillows Mask
Respironics, Inc.
Anesthesiology
155d
Cleared
Jul 12, 2021
Magneto Nasal Mask
Respironics, Inc.
Anesthesiology
153d
Cleared
Apr 30, 2021
Innova Nasal Non-Vented Mask
Sleepnet Corporation
Anesthesiology
142d