Medical device shortage: Z2 Auto CPAP System
The Z2 Auto CPAP System is currently reported as a medical device shortage through Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Interim Order No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the previous interim order) made by the Minister on March 30, 2020. For a full list of shortages, refer to the list of medical device shortages.
Posted on 12-03-2021
Type of report
Actual medical device shortage
Name of medical device (including any component, accessory or part that is in shortage, including the model name) if applicable
Z2 Auto CPAP System
Other names (for example trade name), if applicable
n/a
Package description (for example, packaging formats, sizes, quantities)
Box of 1 Z2 Auto CPAP System with accessories
Class of medical device (I, II, III or IV), if known
Class II
Device identifier(s) (for example, serial number, catalogue number, part number, model number or unique device identifier)
718175
Medical device licence number (for Class II, III and IV), if applicable
103870
Authorization identification number (for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act), if applicable
n/a
Single-use product
No
Importers that have reported the shortage (Names of importers listed who have reported the shortage separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable
n/a
Manufacturer's name
Breas Medical, Inc.
Manufacturer's mailing address
16 Esquire Rd
North Billerica, Massachusetts
United States of America
01862
Reason for shortage
Increase in demand for the medical device
Disruption of the manufacturing of a medical device
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