Medical device shortage: Child/Small Adult Face Mask with Adjustable Air Cushion

The Child/Small Adult Face Mask with Adjustable Air Cushion 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 2021-09-14

Type of report

Actual medical device shortage

Name of medical device (including any component, accessory, consumable material or part that is in shortage, including the model name) if applicable

Child/Small Adult Face Mask with Adjustable Air Cushion

Other names (for example trade name), if applicable

n/a

Package description (for example, packaging formats, sizes, quantities)

Package of 20

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)

6840

Medical device licence number (for Class II, III and IV), if applicable

20571

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

Yes

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

Vyaire Medical, Inc.

Manufacturer’s mailing address

26125 N. Riverwoods Blvd.
Mettawa, IL
United States
60045

Reason for shortage

Increase in demand of medical device